Consultants

EAS Consulting Group, LLC is staffed with former FDA compliance officials and industry experts with many years of regulatory and consulting experience. A quick review of the backgrounds of our consultants will demonstrate that we have assembled one of the strongest teams of experts available in the industry today.

The names listed are the consultants used on a regular basis to assist clients throughout the world. Still others are available through the global network of contacts EAS has established throughout its development. This includes regulatory experts stationed in foreign countries that have knowledge of EU, Canadian and other national standards with whom EAS has established contractual relationships with. If you are looking for someone with a specialized skill, there is a strong possibility that we can find the right person to meet your particular need.

Executive Staff:

Senior Scientific Advisor:

Contract Consultants:

Edward A. Steele – President

Mr. Steele’s 30 years of FDA experience will be of real benefit to you if you are searching for a person who has managed the planning, development, implementation, and evaluation of FDA’s food and cosmetic programs. Add more than 12 years of AAC/Kendle consulting experience, and you will find Mr. Steele to have a wealth of knowledge and experience of value to you.

In 1964 Mr. Steele began his career as an FDA analytical chemist in the New York District. Mr. Steele then moved to FDA Headquarters in Washington DC where he held various positions of increasing responsibility at the Center for Food Safety and Applied Nutrition (CFSAN). In addition to managing FDA’s Compliance and Industry Programs for much of his career he provided support to the Center Director on all science policy matters, established FDA’s Office of Seafood, coordinated international affairs, and managed the Center’s education and technical assistance programs. He holds an MBA in management and has been the recipient of various awards including the FDA Award of Merit and the Meritorious Citation Award.

Since 1994, when he joined AAC/Kendle as Vice President of the Food, Dietary Supplement & Cosmetic Consulting Division, clients throughout the world have been able to take advantage of Mr. Steele’s valuable FDA compliance expertise. Under his leadership, and through the efforts of the outstanding staff that he had assembled, AAC/Kendle was recognized as a global leader in the food, dietary supplement, and cosmetic consulting field. During the last 2 years at AAC/Kendle, Mr. Steele served as President of the Rockville, MD office.

In October 2006 he formed EAS Consulting Group and is serving as President of this independent company.

Elizabeth (Betty) Campbell – Vice President

For formidable expertise in food product regulation, you need Elizabeth Campbell. Ms. Campbell spent 35 years working at the FDA in various capacities such as Acting Director in the Office of Food Labeling at the Center for Food Safety and Applied Nutrition. Her experience can benefit any client that needs advice on food regulations and labels.

After serving 10 years as a Chemist in the FDA’s New Orleans and Atlanta district offices, Ms. Campbell transferred to Washington DC, where she joined the Guidelines and Compliance Research Branch. From there, she moved into other roles culminating in her role as Acting Director in the Office of Food Labeling. Much of her time at the FDA was spent in developing regulations for food, including her instrumental role in writing the regulations under the Nutrition Labeling and Education Act (NLEA) in the 1990s. Once the NLEA regulations were written, she was responsible for implementing important regulations, including training industry personnel and regulatory officials, developing an enforcement strategy, and guiding policy decisions. She also helped to develop current FDA policies on claims under the Dietary Supplement Health and Education Act, and the FDA Modernization Act of 1997. Ms. Campbell participated in the NAFTA Technical Working Group on Packaging and Labeling as the head of the U.S. delegation, and in several Codex Alimentarius committees. She also served as a U.S. delegate to the Codex Committee on Food Labeling.

Joining AAC/Kendle in 1999 as a Senior Consultant has allowed Ms. Campbell to share her extensive experience in food guidelines with clients throughout the world. She is able to review your food labels for compliance with FDA regulations and, work independently to give you expert advice and strategies. Her knowledge also extends to regulations and guidance documents concerning chemical contaminants, filth in food, and other issues gleaned from her years at the FDA. She will be happy to share her expertise with your company.

In October 2006 Ms. Campbell became a Vice President of EAS Consulting Group.

Dean R. Cirotta – Vice President

Dean Cirotta recently joined EAS Consulting Group as part of the group's expansion of services to the pharmaceutical and tobacco sectors. Mr. Cirotta has 22 years of experience in a range of pharmaceuticals firms, including senior management roles with responsibility for regulatory affairs, compliance, quality assurance and overall corporate management.

Immediately prior to joining EAS, he was president and chief operating officer of UPM Pharmaceuticals in Baltimore, Md, a subsidiary of SJ Strategic Investments in Bristol, Tenn. UPM is a mid-sized contract research and manufacturing organization. Prior to UPM he was president and COO of Leitner Pharmaceuticals, a small pharmaceutical company that owned and marketed 2 NDA products.

From March 2004 to March 2006, he was executive vice president of regulatory affairs and quality assurance for SJ Strategic Investments. His responsibilities included regulatory affairs and QA operations for the group's two wholly-owned subsidiaries, Leitner Pharmaceuticals and UPM Pharmaceuticals.

Dean began his career with Glaxo in Research Triangle Park, N.C., where he was a QA Chemist, Associate Validation Specialist, Regulatory Compliance Associate and finally a Senior Regulatory Compliance Auditor. Later he worked with Shionogi Qualicaps, and then Merz Pharmaceuticals as the corporate head of Regulatory Affairs and Quality Assurance for both firms. In 1999, he joined King Pharmaceuticals as a senior director of regulatory affairs. From June 2002 to March 2004, he held senior regulatory affairs positions at the pharmaceutical division of Bausch & Lomb in Rochester, N.Y., first as vice president of U.S. regulatory affairs, then as vice president of global regulatory affairs. He led the international regulatory team responsible for U.S. approval of Zylet and Retisert, two products used to treat eye inflammation.

Mr. Cirotta has a Bachelor of Science degree in chemistry from the University of North Carolina at Greensboro and a Master's degree in business administration from the University of North Carolina at Chapel Hill.

Anthony C. Celeste - Senior Advisor

Internationally recognized as a leading food and drug regulatory authority, Anthony C. Celeste joins EAS Consulting Group, LLC as principal advisor to the EAS President, with primary responsibility for expanding the company's consulting, auditing and training services to the pharmaceutical and related industries. Mr. Celeste is also available to provide expert consulting advice to EAS clients on a broad range of food and drug topics.

Mr. Celeste joins EAS after a distinguished, 50-year career split between serving in senior-level management positions at the Food and Drug Administration and developing and managing one of the nation's most reputable regulatory consulting firms. He served with FDA for 25 years after joining its New York District office in 1960 as a chemist. He held a series of positions of increasing responsibility during his tenure, finally serving as director of the Office of Regional Operations, the Washington, D.C. headquarters unit responsible for managing and directing the agency's field force of investigators, analysts, compliance officers, and administrative staff.

After leaving the agency in 1985, Mr. Celeste served as president and CEO of AAC Consulting Group, Inc., an independent FDA consulting firm, until its acquisition in February 2001 by Kendle International Inc., a global clinical research organization. He retired in January 2010 as Kendle's senior vice president of regulatory affairs, a position he held since 2001.

Charles "Chris" Celeste - Director of Regulatory Information and Submissions

EAS has greatly expanded its regulatory compliance services to the pharmaceutical industry with the addition of Charles "Chris" Celeste as Director of Regulatory Information and Submissions.

Chris joins EAS from Kendle Regulatory Affairs (formerly AAC Consulting Group). EAS was established as an independent company in October 2006, before which it was a division of AAC Consulting Group.

Chris was most recently Director of Regulatory Operations and Intelligence in Kendle's Rockville Office. In this position, he was responsible for preparing and coordinating the submission of various sponsor applications (INDs, ANDAs NDAs, DMFs, and VMFs in non-CTD, CTD, and eCTD formats) to FDA. He has assisted sponsors with the preparation and submission of electronic Drug Establishment Registration and Drug Product Listings, import issues and general regulatory questions. He began working at Kendle (then AAC) in 1990 as a Freedom of Information Act Coordinator. In this role, he was responsible for coordinating all of the activity of the Information Services Division, including, supervising the research associates and the weekly publication of the "FDA News & Information." He has a Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society.

Mr. Celeste's expertise in regulatory submissions for INDs, NDAs, ANDAs, and DMFs, will be an enormous asset to EAS clients.

W. Gary Flamm, Ph.D. - Scientific Advisor

EAS Consulting Group is honored to have Dr. Gary Flamm, former Director of the Office of Toxicological Sciences at the FDA’s Center for Food Safety and Applied Nutrition, serve as our Scientific Advisor. His distinguished 45 years of toxicological experience makes him an invaluable asset to our scientific staff.

After receiving his doctorate in Biological Chemistry at the University of Cincinnati, Dr. Flamm began his career doing research at prominent facilities like the National Cancer Institute. From there he joined the National Institute of Health and then the FDA as the Chief of the Genetic Toxicology Branch. His positions at the FDA have included Associate Director for Regulatory Evaluation in the Division of Toxicology, Bureau of Foods, and the Deputy Associate Commissioner for Health Affairs. Since 1988 Dr. Flamm has been the President of Flamm Associates, a firm specializing in Toxicology and Food Regulatory consulting. He is a Fellow of the Academy of Toxicological Sciences, a charter member of the American College of Toxicology, and has held offices in numerous other national toxicology organizations such as the International Society of Regulatory Toxicology and Pharmacology (ISTRP) and the Environmental Mutagen Society (EMS). He served on the editorial boards of seven journals addressing toxicology and risk assessment subjects and the Guide to U.S. Food Safety Law, as well as serving as chairman of many committees. He has published over 100 papers in scientific journals such as Science and Nutrition, and has been invited to give over 150 presentations in his field of expertise.

It is comforting to know that the scientific advice you get from EAS associates is supported by experts like Dr. Flamm.

Timothy Anderson

Timothy Anderson is an interdisciplined individual, melding comprehensive pharmaceutical industrial R&D, business development, QA/QC, and consultancy experiences with formal FDA-tenured regulatory credentials.

Currently, Mr. Anderson works as a retained consultant. His clients are furnished services in the areas of global regulatory filing review, writing, Agency negotiation, strategic advisories, contracted management services, and executive search. His expertise includes review/writing of Chemistry and Manufacturing Controls (CMC) sections for NDA, ANDA, IND (biologicals and new chemical entities), 505(b)(2), DMF, 510(k), Type I & II, MAAs/CTX and International filings. Other services include cGMP (QC/QA), due-diligence, mock pre-approval inspections, R&D portfolio, and Business Analysis.

Prior to working as a consultant, Mr. Anderson worked for Sandoz Pharmaceuticals Corporation under the Creighton Pharmaceuticals Corporate division. He successfully guided, educated, and project managed the domestic and international regulatory and manufacturing functions within Sandoz, toward preparation and timely submission of Abbreviated New Drug Applications (ANDAs) and Drug Master Files (DMFs) to the FDA for Sandoz products, which have and/or are due to come off-patent. He helped set the standard for review of competing generic filings through preparation of five first-of-their-kind original ANDAs for Clozapine, Cyclosporine, and Bromocriptine dosage forms, as part of a larger strategy to promote Sandoz brand protection.

Mr. Anderson started out working for FDA as a Review Chemist. In this role he drafted coherent deficiency or approval letters in the course of thorough review of chemistry and manufacturing controls sections of original and supplemental ANDAs and DMFs, resulting in fewer required review cycles for applicants. He made contributions to several policy-crafting CDER committees: Chemistry and Manufacturing Controls Coordinating Committees (CMCCC), prepared policy and procedure guides (PPGs) for bioequivalence evaluation of topicals. He also contributed to drug monographs performed in conjunction with preparation of FDA guidances for presentation to the International Conference on Harmonization (ICH).

Douglas L. Archer, Ph.D.

Dr. Archer received a B.A. degree in Zoology in 1968 and a M.S. degree in Bacteriology in 1970 from the University of Maine, and a Ph.D. degree in Microbiology in 1973 from the University of Maryland.

Dr. Archer was appointed Professor and Chair, Food Science and Human Nutrition Department, Institute of Food and Agricultural Sciences, University of Florida, on January 3, 1994. The Department has over thirty faculty and has program foci in nutritional sciences, food science, and dietetics. He served as Chair until January 1, 2001 at which time he returned to the faculty to teach and conduct research.

Prior to his appointment, Dr. Archer served as Deputy Director, Center for Food Safety and Applied Nutrition, U.S. Food and Drug Administration (FDA), where he was charged with oversight of the research, regulatory and policy activities of all foods and cosmetic programs including food additives, food labeling, special nutritionals, seafood, and cosmetics and colors.

During his career with FDA, Dr. Archer was a Commissioned Officer in the United States Public Health Service (USPHS) and was appointed Assistant Surgeon General in July 1990. Furthermore, he received numerous awards including five citations for excellence, three Meritorious Service Medals, and the Distinguished Service Medal. Non-government awards included the 1988 Tanner Memorial Award from the Institute of Food Technologists, in which he is a professional member, and the J. C. Frazier Memorial Award from the University of Wisconsin in 1992. He retired from the USPHS on January 1, 1994.

From 1984 until his retirement in 1994, Dr. Archer served as Chairman of the FAO/WHO Codex Alimentarius Committee on Food Hygiene, and since 1990, has been a member of the WHO Expert Advisory Panel on Food Safety. He is the past U. S. Associate Editor for Food Control, and currently serves on the editorial board for that journal. He is a professional member of the Institute of Food Technologists (IFT), and co-writer of the Regulatory Impact column of Food Technology magazine.

Dr. Archer has authored or co-authored more than eighty peer-reviewed scientific publications, and given hundreds of presentations to scientific organizations, trade organizations, and consumer groups.

Dr. Archer is a member of the Food and Drug Administration's Food Advisory Committee.

Joseph R. Baca

Mr. Baca worked for FDA for over 37 years. During his distinguished federal career, he worked in the FDA field and headquarters offices. He worked on the regulatory aspects of all of the commodities regulated by the Agency. He also managed nearly all of the regulatory tools available to FDA including administrative, civil and criminal actions.

He was the Director of the Office of Compliance, Center for Food Safety and Applied Nutrition (CFSAN) from 1999 to 2008. There he directed the office which was responsible for managing import and domestic regulatory matters for foods and dietary supplements. This required him to work with other offices in CFSAN and with Center management to make decisions on recommendations from the FDA Field Offices related to it initiating and managing regulatory actions. The Office of Compliance was also responsible for preparing the FDA field work plan and objectives for each fiscal year and for preparing, issuing and evaluating special assignments issued to the FDA Field Offices. He also had responsible for cooperative programs in Grade A dairy, shellfish and retail foods. In this capacity he worked with the states, counties, municipalities, foreign countries and the regulated industry to assure safety and consistency in these areas.

Prior to moving to FDA headquarters in 1999, he held increasingly responsible positions in various FDA field offices. From 1996 to 1999 he was the District Director for the FDA Dallas District Office. As District Director he was responsible for the overall management of a large FDA Field Office including a significant portion of regulated imports from Mexico. From 1987 to 1996 he was the Compliance Branch Director, FDA Seattle District Office. There he was responsible for many import and domestic cases in imported foods, devices, biologics and veterinary areas. From 1977 to 1987 Mr. Baca was a Compliance Officer in the FDA Minneapolis District Office. In Minneapolis he managed a significant caseload in various domestic and imported commodity areas including foods, drugs, veterinary drugs, biologics and medical devices. He started his FDA career as a chemist in the Minneapolis District Office in 1971.

He is now available to share his FDA compliance knowledge and experience with EAS clients. Mr. Baca has a BS degree in chemistry. His hobbies include bicycling, gardening and woodworking.

Robert W. Becker, Jr. - Senior Consultant

If you are looking for an internationally recognized expert in Seafood HACCP, with 35 years of FDA experience and more than 6 years of consulting experience, you will be pleased to know that Robert Becker is available to assist your firm develop and implement HACCP controls.

Mr. Becker joined EAS in October 2006 as a Contract Consultant after having worked for AAC/Kendle since January 2001. Prior to joining the consulting ranks, he had 35 years of inspectional experience working for the FDA as a Consumer Safety Officer and as a Regional Seafood Specialist. Among other responsibilities, he credentialed Seafood HACCP Inspectors under FDA’s Seafood Certification Program. FDA called upon him to conduct the most complex seafood regulatory inspections throughout FDA’s Southeast Region, to consult with State and Sea Grant personnel on seafood issues, and to train over 1,200 federal and state regulators via live satellite when the Seafood HACCP Regulations were finalized. He is an AFDO Certified Seafood HACCP Trainer.

Mr. Becker is available to conduct HACCP audits, write HACCP plans, and conduct HACCP training courses for seafood warehouses and processing facilities, juice processors, or other food facilities that use HACCP to control potential hazards.

Leslie Bluhm, Ph.D. - Senior Consultant

Dr. Leslie Bluhm has more than 41 years of experience both directing and overseeing Food Processing regulatory policy for the Center for Food Safety and Applied Nutrition (CFSAN) and in industry managing technical R&D activities with major international corporations. We are pleased that Dr. Bluhm is now available to share his extensive expertise in HACCP, food GMPs, SSOPs and other food safety related areas with EAS clients.

Dr. Bluhm began his career in industry with Miles Laboratories Inc. (a subsidiary of Bayer A.G.) as a research scientist and later became Director of Food Science Research, developing high technology food ingredients in diary/food microbiology enzymology, brewing and fermented foods. He later joined Joseph E. Seagram & Sons, Inc. in various capacities, including Vice President/Director of Technical Affairs, where he oversaw all management of chemical, microbiological and regulatory aspects of the company's operations both domestically and internationally.

Senior FDA positions held by Dr. Bluhm include Director, Division of HACCP programs, and Director, Division of Field Programs in CFSAN, where he managed a multi-faceted program piloting voluntary HACCP across the spectrum of the food industry, managed the Low Acid and Acidified Canned Foods firm registration, oversaw the Laboratory Quality Assurance Branch functions in accrediting state laboratories in the analysis of milk products and shellfish and managed the Compliance Program and Compliance Policy Guide document origination and updates for the Office of Compliance that identifies CFSAN's investigational field requirements and guidance for FDA field staff. He was also Deputy Director of Food Chemistry and Technology for the National Center for Food Safety and Technology in Chicago managing a multi-disciplined research program in the fields of food processing and packaging.

Dr. Bluhm's consulting work includes developing and leading a week long "Train the Trainer" course dealing with the U.S. Seafood HACCP Regulation and the requirements to export seafood products to the U.S. He led a mission to assess the technical competency of the Institute of Food Technology and food processing facilities in Senegal. He was part of a team that evaluated the Food Safety and Quality Agency in the Ministry of Health of the Malaysian government.

Dr. Bluhm received a B.Sc. in Food Science and Technology from the University of Massachusetts, Amherst. He received his M.S. and Ph.D. in Food Science and Technology from the University of Illinois, Urbana. Dr. Bluhm is a HACCP certified instructor.

Dr. Hae Rang Chung

Dr. Hae Rang Chung of Seoul, Korea—a former head researcher with the Korea Health Industry Development Institute (KHIDI) and a former visiting scientist at FDA's Center for Food Safety and Applied Nutrition—is now collaborating with EAS to facilitate work with our Korean clients through KHIDI.

Dr. Chung's career included almost six years as director of KHIDI's Quality Evaluation Center (1999-2004). She spent two years as a visiting scholar at the University of Connecticut's Department of Nutritional Sciences.

Since July 2007, Dr. Chung has been president of Nutrition for the Future, Inc., providing food and nutrition consulting services. She has a Ph.D in nutrition from Ewha Women's University in Seoul.

Dr. Chung's understanding of the regulatory environments in both the United States and Korea will be a major asset for EAS clients.

Richard Debo

Microbiologist and former FDA official Richard Debo has been a member of the EAS team as a senior consultant for several years. His 37-year federal career included roles as an investigator, a compliance officer, a trainer and a director of field operations.

A leading expert in HACCP, he was the agency's very first HACCP-trained investigator in the early 1970's and he participated in the drafting of the Seafood HACCP regulation that went into effect in December 1997. He served in the agency's Atlanta District Office and the New Orleans District agency where he became the director of field operations.

Mr. Debo served as the training and professional development monitor for the Atlanta District office. In this role, he provided training in microbiological analytical methodology and inspection of food processing plants. He developed a seafood inspection training course that was given to all the agency's investigators in the southeast region.

Shrikant Dighe

Dr. Dighe has more than 30 years of experience as a research scientist, review scientist and scientific manager. He has also spent more than 20 years with the Food and Drug Administration (FDA). He possesses broad scientific expertise in medicinal and organic chemistry, biopharmaceutics, pharmacokinetics, analytical chemistry, instrumental analysis, pharmacology and statistics. He is skilled in setting up and implementing division policies, evaluating, editing and writing scientific reports and supervising and coordinating review activities of scientific reviewers. He has represented FDA at various national and international forums and made numerous presentations at meetings and symposia. He has also published a number of scientific articles, prepared over hundred guidance documents and jointly edited three books.

Since 1994, he has been working as a Pharmaceutical Consultant providing advice and consultation to pharmaceutical industry in the area of pharmacokinetics, bioavailability, bioequivalence, analytical method validation, dissolution testing and FDA regulations concerning pharmaceutical products.

From 1973 to 1994 he worked for FDA and held the title of Director, Division of Bioequivalence until leaving the Agency. He helped set up the new division and directed its expansion and development. He set up policies and requirements for bioequivalence of generic drug products to implement the Drug Price Competition and Patent Terms Restoration Act of 1984. He supervised and coordinated review and evaluation of bioequivalence data and ANDAs and trained scientists in the ANDA review process. He wrote and edited over a 100 guidance protocols for in vivo bioequivalence studies and dissolution testing.

Dr. Dighe holds a B.Sc. in Chemistry and Physics from University of Bombay, India and a PhD. in Organic Chemistry from University of Cincinnati, Ohio. He also has a Masters in Administrative Services from The Johns Hopkins University in Baltimore, MD.

Gloria J. Dunnavan – Senior Consultant

If you need an expert in Animal Drugs or Feed Regulations, you need to speak with Gloria Dunnavan. Ms. Dunnavan had over 35 years of government experience before becoming an Independent Consultant in 2008.

Ms. Dunnavan worked as an FDA Field Investigator in Nashville, Tennessee and Louisville, Kentucky. From 1979 to 1997, she worked as a Compliance Officer in FDA's Center for Veterinary Medicine (CVM) in Washington, DC. In that position, she handled the Center's most complicated and precedent-setting enforcement actions. For the next ten years Gloria served as CVM's Director, Division of Compliance. She spent her last year at FDA in the Office of Compliance at FDA's Center for Food Safety and Applied Nutrition working on a special project for the Agency's Import Strategic Plan.

Ms. Dunnavan has had extensive experience working with organizations outside of FDA as well. She worked with EU representatives on a Mutual Recognition Agreement for drugs; interacted with foreign government representatives on a BSE regulation; and was the Federal representative to intra and interagency work groups comprised of federal, state and/or local officials. She was also active in several groups consisting of public and private participants including: the Food and Drug Law Institute, Association of Food and Drug Officials, Association of American Feed Control Officials, and the US Animal Health Association. She is a frequent speaker on CVM matters, and has been involved with planning and conducting numerous large nationwide training sessions and workshops. She has received numerous honors and awards including Vice President Gore's Hammer Award, FDA's Award of Merit, and HHS Distinguished Service Awards.

She joined EAS as a Contract Consultant in November 2008. We are delighted to have her on our team.

Bruce D. Elsner - Senior Consultant

Mr. Elsner has over 28 years of experience at three Fortune 500 corporations and 14 + years of experience in his own consulting company. This has given him a real world, in-depth knowledge of cGMP compliance requirements and considerable expertise in quality systems development and improvement - all in a manufacturing environment. This experience covers the world of ethical and OTC drugs, cosmetics, medical devices and dietary supplements.

In 1968, Mr. Elsner began work at what was then E. R. Squibb & Sons, Inc. managing process support and control laboratories. This included fermentation culture development and monitoring, bioassay testing and chemical analysis. This led to responsibilities for process control management of complex fermentation processes for antibiotics, steroids and enzymes and associated process improvement successes.

Mr. Elsner's next assignment in 1974 was in a divisional technical services role with Richardson-Vicks, Inc. His work included management of a pilot plant and a package testing laboratory. Here he was responsible for translating R&D formulations into production scale processes, identifying and recommending production equipment, creating master batch production records and training production plant personnel on all new or revised formulations, processes and control procedures across three plants. He was also responsible for developing standardized package testing protocols and created a package testing manual for evaluating proposed prototype packages prior to approval for production use. His role then shifted in 1984 to plant QA manager in which he was responsible for implementing improvements to quality systems, overall management and expansion of a sophisticated analytical laboratory, management of a microbiology laboratory and plant quality control operations.

In 1988, following the acquisition of RVI by Procter & Gamble, Mr. Elsner led multiple quality systems transition teams addressing validation, vendor quality, stability, computer systems, copy/artwork, GMP self-inspection and others. This work also included active participation in the Health & Beauty Care Sector Quality Council and resolution of quality and cGMP issues at the corporate level. In 1991 his role as Group Manager - QA Capability & Standards involved managing an electronic specifications and standard procedures program across all plants, contract sites and the Health Care and Beauty Care R&D groups. This also included responsibility for cGMP auditing and quality systems improvement work that doubled QA capability ratings at 4 plants and 30 contract manufacturing sites.

Since 1996, Mr. Elsner has been operating his own consulting business working with companies producing drug, dietary supplement and cosmetic products. This work includes cGMP compliance assessments, development of master plans for managing improvement needs, coaching and hands-on work to develop standard operating procedures, validation master plans, validation protocols and quality control procedures. These efforts have led to many companies passing FDA inspections with flying colors and contract manufacturers being highly rated by their client companies and being considered preferred suppliers.

Mr. Elsner joined EAS as a contract consultant in April 2010. He is available to help meet your needs for developing and implementing practical improvements in the areas of cGMP compliance, quality systems and standard operating procedures.

Faye J. Feldstein

Ms. Feldstein was a resourceful and highly productive senior FDA manager with substantial experience directing highly skilled scientific and technical staff in food regulatory, research and policy program areas. She has prior experience as a successful food safety/quality assurance executive for a large manufacturing facility with a complex food processing environment. Her management skills are complimented by professional qualifications in microbiology and food science/technology.

Faye Feldstein recently joined EAS Consulting Group after ten years with the Food and Drug Administration--most recently as acting director of the Office of Food Defense, Communications and Emergency Response. From May 2006 to June 2010 she was the Deputy Office Director and then filled the position of the Director on an acting basis when Dr. David Acheson moved to the Commissioner's office. In those positions she provided executive leadership and management to a staff of 100 scientific, technical, professional, and support personnel engaged in such disciplines as bioinformatics, risk assessment, food defense, risk communication, consumer education, epidemiology, and adult learning. From January 2002 to June 2006, she was director of the Division of Cooperative Programs at CFSAN. There she was responsible for four interdisciplinary teams within the Division, including the Laboratory Quality Assurance Team, Shellfish Safety Team, Milk Safety Team and Retail Food Protection Team. Prior to that role, she was a consumer safety officer in the Division of HACCP Programs.

Before joining the agency, she spent 12 years with the culinary manufacturing division of W. R. Grace and Co., beginning as director of quality control and advancing to become vice president and plant manager. During her 12-year tenure, the division never had an outbreak or a classified recall of any product.

A recipient of many agency awards, she received the FDA Outstanding Service award in June 2010. She holds a Bachelor of Science degree in microbiology and a Master of Science degree in food science from the University of Maryland.

Her food safety experience acquired at FDA and her practical industry experience coupled with her academic training makes Faye Feldstein a valuable resource to EAS clients as they prepare for FDA's implementation of the Food Safety Modernization Act.

Donald F. Fernholz – Senior Consultant

Mr. Fernholz has more than 41 years of inspection experience to offer EAS clients. He served 32 years with FDA and another 9 years conducting audits and serving as a consultant of FDA regulated industries throughout the United States for AAC/Kendle before joining EAS as a contract consultant in 2006. He has a strong background in inspecting all FDA regulated products.

Mr. Fernholz began his FDA career in 1964 as an Investigator at the FDA St. Louis District Office. After working for a short time as a Special Investigator for the Minnesota State Health Department he returned to the FDA to work as an Investigator in the Minneapolis District Office. He then transferred to the FDA Chicago District Office where he worked as an Investigator for seven years. There he continued to develop his expertise in all areas of food manufacturing and warehousing, dietary supplements, cosmetics, convenience food manufacturing, and pharmaceutical manufacturing to include small volume injectables and other dosage forms.

His next position was that of a Senior Resident Post Investigator located in Fargo, North Dakota. After four years in that position he was selected as a Supervisory Investigator in charge of a new Field Resident Post located in Akron, Ohio. During his management of that office he worked closely with State and Local health officials, and cooperated and assisted industry in bringing their operations into compliance with FDA regulations. Mr. Fernholz held the position of Supervisory Investigator for 20 years and during that time was in charge of the FDA Resident Posts in Akron, Cleveland, Youngstown, Toledo, and Columbus, Ohio. He was in charge of 21 Investigators in those offices who made inspections/investigations of firms who manufactured or distributed all the types of products covered under FDA regulations.

Mr. Fernholz joined AAC/Kendle as a contractor in 1997 as a Senior Consultant. He has provided expert advice on FDA requirements and regulations to clients and has performed audits of manufacturing facilities throughout the United States. He conducted comprehensive audits of food manufacturing and warehousing facilities, dietary supplements manufacturers and Good Agricultural Practices (GAP) of produce growers and distributors. He has also presented training on Good Manufacturing Practices (GMP) regulations and on the proposed Dietary Supplement regulations.

At EAS he is available to conduct audits of FDA regulated firms, provide expert regulatory/manufacturing advice, and develop and implement training programs which address FDA regulatory requirements. If you have a need for audits, expert consultation advice, training, or regulatory compliance advice, Donald Fernholz is ready and willing to go to great lengths to help you.

Robert (Bob) C. Fish – Senior Consultant

EAS Consulting Group is fortunate to have a person with more than 45-years of FDA and consulting experience to assist you in your dietary supplement and pharmaceutical regulatory needs. Mr. Fish served 33-years with FDA and another 11-years conducting audits of pharmaceutical firms as well as other FDA regulated companies throughout the world for AAC/Kendle before joining EAS as a contract consultant in 2006. He is ISO 9000 Lead Assessor Trained and an AFDO Certified HACCP Instructor. He is a recognized expert in all areas of auditing and training concerning FDA regulatory requirements with specializations in the area of dietary supplements and pharmaceuticals.

Mr. Fish began his career in 1962 as an Investigator at the FDA Minneapolis District Office. In that position he conducted inspections and investigations in all areas of products regulated by FDA. He next served as a Resident Investigator at the Grand Rapids Resident Post. In this capacity he continued activities in all areas of FDA regulatory responsibility, including foods, dietary supplements, and pharmaceuticals.

He next served at the FDA Detroit District Office as a Specialist Investigator. There he performed inspections and investigations in all areas of FDA regulated industry, with a specialty in the pharmaceutical area.

His supervisory management experience began in 1972 as a Supervisory Investigator in the Nashville District Office. He held this position for 8-years and was responsible for the training and evaluation of a group of 8-12 Investigators. He was responsible for assignment of work, review of work products, and compliance recommendations.

His next position was that of Director of Compliance at the Nashville District Office, a position he held for 8-years. In that position he supervised staff responsible for review of individual company compliance and recommendation of appropriate administrative/ regulatory actions.

Mr. Fish's final position with FDA was as Director, Division of Field Investigations (DFI)--the Agency's "Chief Inspector." He was responsible for general policy and guidance for the Agency’s domestic and international investigational activities. He also managed the foreign inspection operations, and for 4-years managed the headquarters oversight of field Import Operations.

Mr. Fish joined AAC/Kendle in 1995 as a Senior Consultant. He provided regulation advice to clients and performed audits of pharmaceutical manufacturing facilities throughout the world. He also served as the Manager of Audits while at AAC/Kendle.

At EAS he is available to conduct audits of pharmaceutical companies as well as supplement processing facilities. He can develop and implement training programs which address FDA regulatory requirements. If you have a need for audits, training, or regulatory compliance advice, particularly in the pharmaceutical or dietary supplement area, Bob Fish is the expert you need.

Janice K. Gardner

Ms. Janice Gardner has more than 20 years of food safety and regulatory compliance experience. She was a Senior Sanitarian for the State of Wisconsin for six years; an Investigator for the FDA for eleven years; and is now an independent food consultant specializing in interstate travel sanitation, retail food safety, disease control and outbreak management and seafood HACCP. Ms. Gardner resides in Honolulu Hawaii.

She conducted retail food establishment audits of over 800 licensed facilities for the Wisconsin Department of Health and Family Services from 1993 to 1999. Her other duties for the State included reviewing and approving plans for food preparation facilities and inspecting private water supplies and sewage disposal systems.

In February, 1999 she joined FDA as a Consumer Safety Officer/Investigator responsible for conducting audits of food processors, retail food and airline catering facilities, aircraft ground services and cruise ships. She trained and advised the regulated industry on food safety handling practices, employee hygiene and facility sanitation. She was responsible for all interstate travel work for the Oceania region including conducting construction plan reviews for cruise ships and food processing facilities.

Ms. Gardner holds a BS degree from Upper Iowa University. She is a NEHA Registered Environmental Health Specialist (REHS)/Registered Sanitarian (RS). She has been Standardized in the FDA Food Code, has a ServSafe Certificate (2009) and is the recipient of various FDA awards, including the Outstanding Service Award for activities related to outbreak investigations.

Sidney Green, Ph.D. – Senior Consultant

Dr. Sidney Green joined EAS's scientific team in 2006, and offers clients a broad-range of industry, government, and academic expertise. He serves on Expert GRAS Panels and he is available to assist in evaluating the safety of food and dietary ingredients.

Dr. Green is an Associate Professor of Pharmacology at the Howard University College of Medicine in Washington D.C. He received his Ph.D. in Pharmacology from Howard University in 1972. He has held positions at Covance Laboratories, Inc., Vienna, VA as Director of Toxicology (1995-1998), and at the FDA where his career spanned 29 years. While at the FDA he served as Director of the Division of Toxicological Research, Associate Director for Laboratory Investigations, Chief of the Whole Animal Toxicology Branch, and Chief of the Genetic Toxicology Branch. He also served at the EPA as Chief of the Toxic Effects Branch in the Office of Toxic Substances (1979-1980). Dr. Green has over 70 publications, primarily in genetic toxicology, short-term test methodology, and policy issues associated with alternatives to toxicological animal tests. In addition, he has expertise in systemic toxicology related to food additives and contaminants.

Dr. Green received the FDA Commissioner’s Special Citation, two Group Recognition Awards, and twice received the FDA Award of Merit--once as a group award and once singularly. That award is the highest honor the Agency can bestow on employees. He has served on numerous National Academy of Sciences review committees and currently is a member of the Committee on Toxicology. He is a past President of the American College of Toxicology, Academy of Toxicological Sciences, National Capital Area Chapter of the Society of Toxicology, and the Association of Government Toxicologists. He is a member of the Society of Toxicology, Environmental Mutagen Society, the Society for In Vitro Biology, Organization of Black Scientists, and the Association of Government Toxicologists. He is a past Chairman of the Membership Committee and past member of the Council of the Society of Toxicology. He is on the editorial boards of the Journal of Applied Toxicology, Human and Ecological Risk Assessment, Human and Experimental Toxicology, and the Journal of Toxicology-Cutaneous & Ocular Toxicology.

Beatrice (Bea) Greenberg

Bea Greenberg is a former head of the labeling regulation implementation team in FDA's Center for Food Safety and Applied Nutrition. Following her retirement from the agency in December 2008 she agreed to assist EAS clients on a consulting basis.

Ms. Greenberg began her FDA career as a field investigator in the Philadelphia District in 1977. During her career as an investigator, she conducted inspections in a variety of FDA regulated industries. For several years, she served as Philadelphia District's recall co-coordinator. Prior to moving to the Washington, D.C. area, she served as a Compliance Officer in the Philadelphia District office. While in that position, she participated in several details to CFSAN to assist staffers in reviewing comments received on the proposed Nutrition Labeling and Education Act regulations. She also assisted in FDA's NLEA training efforts and in the implementation and enforcement of the NLEA regulations.

When she relocated to Washington, D.C. in 1997, she first served as a recall coordinator for the Center for Biologics Evaluations and Research. In March 2002, she joined CFSAN to work once again on food labeling issues.

"I am very pleased to have someone with Bea Greenberg's unsurpassed experience of labeling on the EAS team," says EAS President Ed Steele.

James E. Hoadley, Ph.D. – Senior Consultant

EAS is pleased to add a regulatory scientist with Dr. Hoadley’s experience to our list of contract consultants. He recently retired from FDA and joined EAS in October 2007.

Dr. Hoadley’s 20-year FDA career, which began in 1987, includes work as a Research Scientist in the Center for Food Safety and Applied Nutrition (CFSAN), Division of Nutrition, and as a Toxicologist in performing food additive and GRAS petition safety reviews in the Office of Premarket Approval.  With the passage of the Nutrition Labeling and Education Act (NLEA) he participated in the development of NLEA-implementing nutrition labeling and health claim regulations.

Over the past ten years, Dr. Hoadley’s position had been as a Senior Regulatory Scientist in the Office of Nutritional Products, Labeling and Dietary Supplements (ONPLDS) with primary responsibilities in food label claim regulations.  In this role, he conducted scientific and regulatory reviews of petitions for new health claims and nutrient content claims.  During this period Dr. Hoadley was involved in some of the most precedent-setting health claim regulatory problems as CFSAN adapted to the FDA Modernization Act provision for authorization of food label claims based on authoritative statements, the 1999 Pearson v. Shalala federal court decision that led to qualified health claims, and Pearson-related lawsuits.

Dr. Hoadley has been directly involved in the scientific review and drafting of authorizing regulation, or denials, of nearly all health claim petitions received by CFSAN over the last decade.  Dr. Hoadley has received the CFSAN Distinguished Career Service Award.

Dr. Hoadley earned his Ph.D. in Toxicology at the University of Cincinnati College of Medicine, and did postdoctoral research in Nutrition at the University of Florida.  His Bachelor of Science degree is from Ohio State University with a Major in Agricultural Education.

Steven M. Huntoon

Me. Huntoon is a Food Safety and Quality (FS&Q) professional with extensive food service and consumer product experience in fresh and cultured dairy, oil-based, baked, frozen, meat, seafood, confections, fresh produce and nut category manufacturing, technology, and business related issues.

He has 39 years of food industry experience. Twenty six (26) years of which were spent working for Kraft Foods; 2 years for Phillip Morris Management Corporation; 7 years for Fresh Express; and the last 5 years as an independent food safety consultant.

At Kraft he held various positions ranging from Laboratory/Quality Manager; Senior Research Scientist; Manager of Worldwide Quality Systems and Audits; to Manager of Quality Chain Management System for North America. His responsibilities included implementation of Kraft quality programs, developing and implementing worldwide assessment protocol for and safety and manufacturing quality, and developing quality management performance.

He was the Worldwide Quality Systems Manager for Phillip Morris. His duties there included defining common quality and acute product safety requirements of all Phillip Morris product categories. While at Fresh Express he developed the Fresh Express Quality Management System.

Since 2006, Mr. Huntoon has become industry consultant taking on propriety food safety and quality system assignments. In 2010 he became available to assist EAS clients with their food safety needs.

Mr. Huntoon has a BS degree from Iowa State University and a MS degree in Biochemistry from the University of Illinois.

John W. Jones, Ph.D.

Dr. John Jones is a consultant on international food safety and trade issues. He holds a Ph.D. in Analytical Chemistry from the University of Maryland. From 1972 until 2006, he worked in increasingly responsible positions at the United States Food and Drug Administration (FDA). Most of his FDA career was at the Center for Food Safety and Applied Nutrition (CFSAN) and the last position he held at FDA prior to his retirement was Associate Director for Asia and the Pacific, Office of International Programs, Office of the Commissioner, where he coordinated FDA's interactions with counterpart agencies in Asia.

After retiring from U.S. Federal Service in 2006, he accepted an appointment as Senior Fellow at the Joint Institute for Food Safety and Applied Nutrition (JIFSAN) at the University of Maryland where he participates in JIFSAN's international education and training programs. He is also the principal in his own firm, Food Safety Consulting Services International, LLC.

During his early career at FDA, Dr. Jones was a laboratory scientist specializing in analytical methods development for chemical contaminants in foods. Subsequently, he assumed senior management positions at the agency, including those of Program Manager and Strategic Manager for FDA's Pesticide and Chemical Contaminants Program. In these positions, he was responsible for coordinating FDA's national monitoring and enforcement programs for pesticide residues, environmental chemical contaminants and natural toxins. He designed many of FDA's compliance programs in this area and coordinated their implementation nationwide.

As Associate Director for International Affairs at FDA CFSAN, he developed very broad international experience, traveling to over 25 countries on food safety policy and technical issues. Most of these activities were associated with enforcement and compliance matters bearing on the safety of foods imported into, or exported from, the United States. A number of the these activities were related to assisting developing countries in establishing and implementing effective risk management strategies to address food safety concerns. For example, he coordinated FDA's interactions with the World Health Organization's (WHO) Global Environmental Monitoring System, a program designed to assist developing countries in establishing viable national monitoring programs for pesticides and chemical contaminants in foods.

He also served on U.S. delegations to the World Trade Organization's Committee on Sanitary and Phytosanitary Measures (WTO SPS), which develops guidelines for implementing fair trade practices bearing on food safety, and the Codex Committee on Pesticide Residues (CCPR). As a temporary adviser, he assisted the WHO, the Food and Agriculture Organization (FAO) and the United Nations Development Program (UNDP) on various food safety matters.

Dr. Jones has exceptional experience with, and knowledge of, the Chinese food sector. For nearly 30 years, he has worked closely with Chinese government food safety regulatory agencies and with the Chinese food industry. His network of food safety associates inside China is extensive and he has a particularly strong working relationship with influential government and food industry officials in China. In that context, he brings very strong credentials to EAS that can assist both U.S. and Chinese food companies in strengthening and expanding their food marketing opportunities in the two countries, such as in the seafood, dairy product, canned food, fruit and vegetable and dietary supplement sectors.

Denis Kluba - Senior Consultant

Mr. Kluba has brought US, EU and other international regulatory compliance experience to the numerous firms, having worked with Invitron Corporation, Raytheon Engineers & Constructors, AAC Consulting, Washington Group, Integrated Project Services, ProPharma Group and Middough, Inc, developing, executing, and coordinating compliance requirements and projects. During his career, he has designed and performed programs for both pharmaceutical industry suppliers and healthcare industry operations.

Mr. Kluba has consulted on a variety of projects, managed small and large team efforts on-site, and created Commissioning and Qualification Master Plans and protocols to meet specific client operational needs for major projects, operational expansions and R&D operations including technical transfers. His basic philosophy is to improve overall operations while meeting regulatory requirements. His client list includes biopharmaceutical, bulk pharmaceutical chemical, pharmaceutical, solid dosage form, diagnostic, veterinary, and medical device firms.

James H. Knight – Senior Consultant

Mr. Knight has over 30-years experience in GMP-regulated environments. He started his career with Baxter-Travenol in their Kingstree, South Carolina facility. His initial assignment was to establish the site's first GMP-Compliant Microbial Limits Testing Laboratory. When the division was sold to Gist-Brocades, he became the Laboratory Manager for the Analytical Chemistry Lab. During the next several years, he was charged with unifying the site's testing methods with those of the Company's European sites.

In 1986, Mr. Knight joined Schering-Plough HealthCare Products. During his 14-year tenure, he was responsible for establishing the first Quality Program for the Division's Pilot Production Facility. The highlight of his career with Schering-Plough was the opportunity to provide technical services for their international business unit. In this function, he worked with 70 offshore subsidiaries, licensees, and distributorships providing support for their new-product launches and line extensions, as well as providing direction for GMP compliance.

In 1999, Mr. Knight started a consulting business bringing his GMP experience to universities, pharmaceutical, cosmetic, and biologics industries. He has traveled to over 30 international sites while inspecting, developing and improving Quality Programs.

In 2000, Mr. Knight joined St. Jude Children's Research Hospital as the Quality Assurance Director for the production of biologics used in St. Jude's clinical trials, while continuing to work as an Independent Consultant. In his role as QA Director, he established and staffed the Quality Assurance organization for new Department of Therapeutics Production and Quality to establish and maintain a high-level of GMP compliance. He was responsible for writing and editing over 200 Standard Operating Procedures, over 200 Mater Batch Records, and 200 Release Specifications within the first year. He established an equipment calibration program and preventive maintenance program, developed an environmental monitoring program, established a validation program, including IQ, OQ, and PQ on all equipment as well as a software validation program, and established a process variance program.

In 2006, St. Jude established Children's GMP, LLC where Mr. Knight continues to serve as Secretary of the organization and QA Director. He joined EAS Consulting Group as a Contract Consultant in October 2008.

Simone Koenig - Senior Consultant

If you are seeking advice on European regulatory affairs from someone who has many years of practical industry experience in the nutrition and health sector you may wish to contact Simone Koenig.

Ms. Koenig holds a Master's degree in Food Science & Technology and an additional degree in Human Nutrition, from the Swiss Federal Institute of Technology in Zurich (ETH). She joined the Vitamins & Fine Chemicals Division of F. Hoffmann-La Roche in Basel, Switzerland in 1988. While there, she held various positions within technical and science-based marketing, product form development, application labs, and technical services.

It was her expatriate assignment with Roche Canada from 1994-1997 that strengthened her regulatory affairs experience. After her return to Europe she worked for more than four years in the Global Regulatory Affairs Department of Roche Vitamins. Her field of activities at the international level included food legislation, food additives, certain physiologically active substances, and health claims. She was also was involved in committees of Codex Alimentarius. In 2002 she joined the Regional Regulatory Affairs Group of Roche Vitamins Europe. There she was in charge of regulatory business support for the food, pharmaceutical, and cosmetic industry in all European countries (EU and non-EU), Middle East, and Africa. In early 2005, after the transfer of Roche Vitamins to DSM Nutritional Products, Ms. Koenig assumed the position as Head Regulatory Affairs Human Nutrition and Health for Europe, the Middle East, and Africa.

She has more than 18 years of experience working for suppliers of nutrients, additives, functional ingredients and fine chemicals, manufacturers of feed, food, food supplement, pharmaceutical, and cosmetic products. Ms. Koenig gained a comprehensive understanding of the factors ruling the decisions in the nutrition & health and related business as well as at national and international regulatory bodies.

Simone Keonig is available to provide consulting services to clients from the private and public sector involved in the manufacturing, distributing or controlling food, pharmaceutical, and cosmetic products and ingredients. She offers balanced advice on regulatory, quality and safety-related issues and requirements, strategic direction and management expertise. She joined EAS Consulting Group as a Contract Consultant in February 2008.

Gisela Leon - Consultant

For Quality Management Systems in frozen food and ice cream production, Gisela Leon’s 20 years of experience is outstanding. Her ability to streamline quality specifications is proven with her former position. She is also well-experienced in European food laws, multi-language labeling, and legal clearance of package labeling. Additionally, she is versed in U.S. regulatory labeling of food and dietary supplements.

After receiving her Master’s degree in Food Technology Engineering, Ms. Leon received her DGQ Audit-Specialist Certification from the German Institute for Quality, and her Master’s in Business Administration from George Mason University. For over 20 years she worked at Schöller Lebensmittel GmbH & Co KG, becoming a Director of Quality Management. While there she gained a wealth of experience in food law, assuring the marketability of 900 ice cream and bakery products that were sold in 25 countries in accordance with European food labeling laws and country regulations. She also streamlined multi-language labeling to the most efficient and compliant way. Her experience also included quality assurance, as she worked as a Technical Supervisor for 3 ice cream production plants in Germany and the company’s 4–6 foreign plants. She supervised quality assurance for externally purchased frozen foods and baked products, and established the company’s master test plans for raw material and ice cream products. She developed and established HACCP, evaluated raw materials, and ensured comparable methods in product evaluation. She gave presentations at various conferences about ice cream quality. She implemented and sustained the company’s ISO 9001 quality management system both within Germany and in their foreign plants.

If your project calls for management experience in the frozen food industry, Ms. Leon is available for you. She speaks English, German, and French and can give your company first-hand knowledge on European food laws. She can assist your company in assuring your products meet U.S. and EU labeling requirements.

Ms. Leon had 3 years of consulting experience with AAC/Kendle before joining EAS as a contract consultant.

Brian S. Lynch

Mr. Brain Lynch worked for FDA for more than 36 years. He began as a microbiologist at the Center for Toxicological Research (NCTR). Within two years, he transferred to the investigator ranks for the remainder of his distinguished FDA career. He covered all FDA-regulated products while at the Agency and specializing in biologics toward the latter part of his career. He joined EAS as an independent consultant in 2011 after retiring from Federal Service.

He graduated from the University of Louisiana at Lafayette with a BS degree in microbiology in1973 and then completed a year long internship at the Charity Hospital of New Orleans School of Medical Technology, New Orleans, LA. Mr. Lynch then began working for FDA in 1974 as a quality control microbiologist at NCTR. From October, 1976 through 1980 he became a Consumer Safety Officer/Investigator in the New Orleans District Office. It was there that he receive broad experience in food regulatory matters including experience in juice and juice HACCP, warehouse sanitation, bottled water, soft drinks, ice cream, flour mills, rice mills, bakeries, nuts and vegetable oil. In January 1981 he moved to the FDA's Lafayette, Louisiana Resident Post until the end of 1990. He became familiar with the regulations for low acid canned foods (LACF) and acidified foods. He was also trained in seafood HACCP and became knowledgeable about the aquaculture industry and the diseases common to that industry.

During his career he performed inspections/data audits of clinical studies for approved human/veterinary drugs, human medical devices, and injectable cellular products for human use. He performed medical device inspections of a variety of different kinds of devices including latex exam gloves, condoms, and catheters. He also inspected manufacturers of surgical tables and lighting systems. He also performed inspections of drug firms who manufactured finished pharmaceuticals including tablets, capsules, non-sterile liquids, and small and large volume parenterals.

In February 1998 until he retired from FDA in December of 2010, Mr. Lynch specialized in biologics. As the biologic's specialist for the Nashville District Office and the New Orleans District Office he was responsible for the inspection of blood banks, plasma centers, and tissue banks. He was responsible for conducting much of the inspection work conducted by FDA of the American Red Cross while under the ARC consent decree. He has done work in the following industries: blood facilities that collect and process whole blood into blood and blood components for transfusion, including facilities that performed required testing for diseases; source plasma centers including centers that immunize donors with human red blood cells; control laboratories for the source plasma industry that perform the required testing disease states, donor suitability, titer testing for immunized donors; organ procurement organizations that collect boney tissue, ligaments, cartilage, fascia, skin, and human hearts for human heart valve allografts; tissue banks that process the tissue collected by the procurement organization; eye banks, stem cell banks, and reproductive tissue banks; laboratories that performed required testing for disease markers for the tissue industry.

Mr. Lynch is a Level II Investigator in Blood Banks and Plasma Centers since 2001. He help author the systems bases inspection guide to blood banks that was first implemented in 2001.

Jeanette B. Lyon – Senior Consultant

If your needs fall into the retail sector of the food business, we are pleased to offer the knowledge and experience of Jeanette B. Lyon. Mrs. Lyon has extensive regulatory experience working with the retail food store and food service industries. Her specialty is evaluating food systems for risk factors that may contribute to foodborne disease, and helping industry to identify and manage them for the long-term. She is available to write or research regulatory language pertaining to the industry. She is very interested in providing training on issues related to retail food safety.

Mrs. Lyon joined EAS Consulting in October 2006 as a Consultant after having worked for AAC/Kendle International since May 2004. Prior to becoming a Consultant, she worked for 25 years for the State of Maryland. There she achieved the position of Chief of the state’s Food Inspection Program. She initiated the implementation of using the principles of HACCP when conducting food inspections in retail stores and food service establishments. She developed training programs for the state’s sanitarians and assisted them in learning how to apply hazard analysis when conducting inspections. She wrote groundbreaking statewide regulations that prioritized inspection frequency based on the public health risk posed by each establishment, and integrated risk assessment into the plan review process for new establishments.

The last 10 years of Mrs. Lyon’s tenure in government was spent with the FDA's Cooperative Programs Group. After a brief stint dealing with raw molluscan shellfish issues, she again found her calling in the retails food store and food service sector. She contributed to the writing and editing of the Food Code from 1996–2006. She trained other FDA personnel in the techniques needed to successfully write language that complies with the conventions of the Food Code. She was recognized as a National Standard in the interpretation and application of the Food Code. As part of the training cadre in FDA, she wrote and presented numerous sessions to state and local agencies on food safety and the Food Code.

Mrs. Lyon obtained her Master of Health Science degree at Johns Hopkins University School of Hygiene and Public Health (now the Johns Hopkins University Bloomberg School of Public Health), Baltimore, MD. She is a Registered Sanitarian (# 283) with the State of Maryland. She was certified as competent in Retail Food Programs by FDA ORA-U (2004). She is a member of the AFDO Central Atlantic States’ Association of Food & Drug Officials and the American Academy of Sanitarians.

Eduardo (Ed) March - Senior Consultant

Mr. March has more than 27 years of experience working in the medical device regulatory arena within FDA and the medical device industry. He provides advice and consultation to industry on regulatory, technical, and other medical device-related matters. He joined EAS Consulting Group in September 2007 as a Senior Consultant after working as the Director for Quality Assurance & Regulatory Affairs for a Maryland-based biotech company. He also worked as a Regulatory Consultant for AAC/Kendle International Inc., for more than 10 years and now is working for EAS on a contract basis.

Mr. March has degrees in Engineering from Virginia Polytechnic Institute, Post Graduate Engineering from Polytechnic Institute of New York, and Management from Frostburg State University. He also received Certification from the Regulatory Affairs Professional Society.

While at FDA, he specialized in the review, evaluation, and approval of medical devices during the premarket approval processes. From 1981-1989 he was he was a Senior Biomedical Engineering Reviewer in the Office of Device Evaluation; 1989-1993 he was Assistant Director, Division of Standards Enforcement; and he finished his FDA career as a Compliance Officer in the Office of Compliance, CDRH. Mr. March has extensive knowledge of regulatory compliance and quality systems used by FDA to regulate the medical device industry. He has performed pre-approval audits, cGMP audits of medical device manufacturers, and clinical study audits for his clients. He advises clients on the preparation of submissions to obtain approvals--PMAs and IDEs--and clearance 510(k)s to market medical devices. He also assists with the development of quality assurance systems and procedures that comply with the Agency’s medical device regulation (Quality System Regulation).

Mr. March has prepared and conducted training programs of the Agency’s device compliance regulations and approval processes of new devices for his clients. While at FDA in the position of Associate Director for Standards he participated in the development of device-specific voluntary standards for the American Society of Testing and Materials, and the Association for the Advancement of Medical Instrumentation.

You will find Ed March to be invaluable in assisting your device company.

Frank Mark - Pharmaceutical

Frank is responsible for overseeing quality systems and compliance remediation projects for food, pharmaceutical, dietary supplement and medical device R&D and manufacturing operations. As an expert in the application of cGMP regulations, he provides regulatory and technical guidance in the form of training, assessments, mock pre-approval inspections and quality systems remediation. When requested, Frank also acts as an FDA liaison on behalf of clients. Frank's background spans 30 years: More than 10 years as a consultant to the FDA-regulated industries; 13 years' experience in Quality Operations, Research Management and Regulatory Compliance with several established ethical pharmaceutical companies; and seven years as an investigator with FDA's Newark District Office performing comprehensive food, drug and medical device establishment inspections.

Mr. Mark has worked as a consultant on a number of client projects over his career. Some of his work in the area of Quality Remediation includes, assisting clients with implementation and/or remediation of quality systems for development and manufacturing operations, including assessing existing quality systems and assisting with their redesign and/or remediation. In the area of Regulatory Compliance his experience includes assisting clients with performing assessments, audits, mock pre-approval inspections, and providing assistance in responding to FDA 483s, warning letters and other regulatory notifications. He has also assisted in drug master file submissions, pharmaceutical active ingredient readiness projects by performing gap analysis for manufacturing, packaging and quality control operations. He has also performed comprehensive ANDA gap assessments for introduction of new products for the U.S market. He has written validation master plans for new pharmaceutical research and development facilities.

Mr. Mark completed his Bachelors in Chemistry from Jersey City College and completed his MBA from Western Connecticut University. He holds affiliations with International Society of Pharmaceutical Engineers, Parenteral Drug Association and Food and Drug Administration Alumni Association.

Robert Mazzaferro

Robert Mazzaferro offers your company 30-years of medical device experience with the FDA and 7 additional years as a Medical Device Consultant. He joined the EAS Consulting Group as a Contract Consultant in 2007. You will find his understanding of FDA medical device regulations including submissions, engineering, and software to be invaluable.

He started his career as a Commissioned Officer in the US Public Health Service (USPHS) at the Bureau of Radiological Health's Northeast Radiological Health Laboratory and continued to work as an Engineer and Engineering Supervisor when the name of the lab was changed to the Winchester Engineering & Analytical Center. He and his staff tested a wide-range of medical devices that included electronic, mechanical, and radiation producing and measuring devices.

In 1992 he transferred to the FDA's Center for Devices and Radiological Health where he served as a Medical Device Reviewer for 8-years in the Cardiovascular Division of the Office of Device Evaluation. The types of applications that he reviewed included 510(k)s, IDEs, and PMAs. Since retirement in 2000 he has been in the consulting business where he has provided assistance with: medical device submissions and regulations; medical device development; and litigation including civil and criminal cases.

Mr.Mazzaferro is a graduate of Rensselaer Polytechnic Institute of Troy, NY with a Master's degree in Electrical Engineering. He has been licensed as Professional Engineer (PE) in Massachusetts since 1976. During his career at the FDA Robert was promoted to the Permanent Rank of Captain (Navy-equivalent) in the Regular Corps of the USPHS and has received a number of awards including the Outstanding Service Medal and the Commendation Medal. He holds several certifications including: RAC in RAPS (Regulatory Affairs Certification by the Regulatory Affairs Professional Society) since 1994 and CSQE in ASQ (Certified Software Quality Engineer by the American Society of Quality) since 1998.

William Ment – Senior Consultant

If GLP is one of your concerns, William Ment is the consultant you want.  With 34 years of laboratory experience at the FDA, he is able to advise you on laboratory and quality assurance issues.  His experience is broad and far-reaching based on his background.

In his last position, Mr. Ment was the Laboratory Director in Baltimore, MD, with responsibility for a full range of FDA field lab sample analyses and research studies for imported and domestic products, including pharmaceuticals, in vitro diagnostic devices, microbiological, environmental contaminants, and extraneous materials/decomposition in foods.  Since 1970, he has been responsible for developing, implementing and assessing laboratory quality assurance systems and procedures, and training and evaluating personnel in their use.  He has audited operations, QA programs, and procedures of pharmaceutical and dietary supplement firms and FDA field laboratories, including assessment of compliance with cGMPs and ISO accreditation criteria.  His experience also includes analytical methods development and validation, as well as NDA/ANDA method verification testing and compendial monograph assessment.  He has performed PAI and general cGMP audits of API, dosage form, and excipient manufacturers and contractors, and assisted companies in improving laboratory and QC/QA operations, including quality system controls, organizational structure and function, and interaction with manufacturing units.  He has also critiqued the CMC sections of New Drug Application and Drug Master File submissions and performed GLP audits for non-clinical laboratory studies.  Finally, his experience also extends into the dietary supplement area, including training of industry personnel in FDA’s proposed Rule for dietary supplement cGMPs.  Mr. Ment is a member of the American Chemical Society.

Through his unique experience, William Ment is available to assist you with laboratory CGMPs, including laboratory physical facility and environment; staffing; instrument calibration and maintenance programs; SOP assessment and development; sampling; documentation; information and data management systems; reference standards; stability testing programs; analytical method development, validation, change and transfer; out-of-specification (OOS), deviation and batch failure investigations; and responding to issues resulting from FDA inspections.  He is also able to help you with the Chemistry, Manufacturing and Controls sections of your drug applications.  His laboratory experience is inestimable and can be put to work for you.

Chester W. (Chet) Morris – Senior Consultant

The Retail Food Service Industry and special event organizers concerned about food safety and defense issues will find that Mr. Morris has much to offer. This consultant brings 34 years of Agency experience to EAS Consulting Group an Investigator, Certified Senior Retail Food and Milk Specialist, and Director of Federal/State Cooperative Programs.

Mr. Morris started his career in 1972 as a Consumer Safety Officer for the FDA in the Atlanta District Office. With degrees in Food, Sanitary, and Dairy Science, his abilities were used primarily in food investigations. In 1976 he transferred to the Cooperative Programs Branch and served as a certified Milk and Food Specialist. He conducted inspections of food service, food stores, institutional food facilities, dairy farms, and plants throughout his career in the Southeast as he trained state officials, and evaluated state programs. During this period he conducted numerous training courses for State and Local Retail Food Officials and Industry. Food borne illness investigations as well as state and industry conflict resolution were part of his responsibilities. Mr. Morris also assisted with revisions and application of the Food Code. He was a member of the Conference of Food Protection, the Association of Food and Drug Officials, and the Interstate Milk Shipper’s Conference.

When Atlanta won the bid for the 1996 Centennial Olympic Summer Games, Mr. Morris represented FDA on the Olympic Food Safety Committee. The Atlanta Olympic Committee requested that FDA assume the responsibility for food safety and security for the largest Olympic Village in the history of the games. Mr. Morris organized and led a FDA Olympic Village Team that provided 24/7 food safety coverage throughout the games. No food borne illnesses were reported among the over 25,000 Olympians, coaches, and staff in the Atlanta Olympic Village.

Mr. Morris provided food safety, and security training and assistance for the NATO Summit in Washington. He consulted for the Salt Lake Olympic Public Health Committee and served in the Olympic and Para Olympic Village in Salt Lake for a month.

During the 2004 G-8 Summit, Mr. Morris, as the Director of Cooperative Programs Branch, and with his previous experience with special events, organized a team and provided food safety and defense coverage for President Bush, the member world leaders, their guests, and staff on Sea Island, Georgia. As in past events, he worked closely with the U.S. Secret Service, the FBI, Department of Defense, and state public health and agriculture officials to ensure that an effective Food Safety and Defense Program could be carried out.

Prior to his retirement, Mr. Morris received several awards for his work on these high profile events including recognition from the Commissioner of FDA and the White House.

Mr. Morris joined EAS as a contract consultant in September 2007.

Kristi Musgrave - Consultant

Ms. Musgrave has over 13 years of experience in GMP-regulated environments. She started her career with Immuno U.S., Inc. as a Microbiologist in the Quality Control Laboratory at the Rochester, MI facility. Her initial responsibilities included preparing plasma samples for PCR testing and supporting the Aseptic Filling and Production operations through water testing, product testing and environmental monitoring.

Shortly after the Immuno U.S. facility was purchased by Baxter International Inc. she was given responsibility for sterility testing of all final container products at the Rochester facility.

In 1998 Ms. Musgrave was promoted to Microbiology Supervisor and assumed responsibility for the development, implementation, and maintenance of the Quality Control Microbiology testing program. In this role she became a leader in developing a collaborative relationship between the Manufacturing and Quality organizations. This relationship directly contributed to significant improvements in several quality measures such as product bioburden results.

Ms. Musgrave became the Quality Operations Manager at Baxter in 2000 and was responsible for the Quality program within the Plasma Fractionation facility. In this role she helped implement a Nonconformance Management and CAPA system that were benchmarks for the Baxter BioScience division. During her time in this role she led improvement efforts that resulted in a 67% reduction in product bioburden and 25% reduction in manufacturing nonconformances.

For the last six years Ms. Musgrave has worked as a contract consultant with the Validation and Compliance Institute. During this time she has expanded her knowledge of the FDA regulated industries through her work with Medical Device, Pharmaceutical, Biologics, and Dietary Supplement manufacturers. In this role she has implemented quality systems, created supporting Quality documentation, performed facility audits, and created and delivered training. She has also had the opportunity to translate her technical knowledge and that of her colleagues into engaging instructor led and web based course content. Ms. Musgrave is experienced at using rapid e-learning software and e-learning authoring tools such as Articulate Studio.

Ms. Musgrave joined EAS as a contract Consultant in March 2010.

Douglas R. Nelson

Mr. Nelson has 30 years of FDA experience in conducting regulatory inspections/investigations; evaluating food safety control systems, food processing systems, and innovative & complex technologies; and managing Agency personnel and programs.

For 26 years, from 1976-2003, Mr. Nelson served as a food specialist and international inspection program cadre member (LACF/AF and Seafood HACCP) in the Minneapolis District Investigations Branch. There he was the District's Team Leader and Project Manager for four major program areas: (1) LACF/AF Program, (2) Pesticides in Food Program, (3) Mycotoxins and Natural Toxins in Food, and (4) Food and Animal Feed Contaminates Program.

During the last 4 years of his FDA career he was the International LACF Inspection Coordinator for the CFSAN LACF Team, College Park, MD (stationed in Green Bay, Wisconsin). He interacted with the international & domestic food and food container industry, coordinated with FDA counterparts in South and Central America to develop cooperative and interactive inspection trips, and personally participated in most international cooperative and interactive international LACF inspection trips from 2003 through 2006. He developed outreach training program in collaboration with colleagues and associates in FDA, as well as those in academia and industrial sectors. He was an FDA expert in the evaluation of thermal processing and packaging systems. He conducted regulatory review of aseptic processing and packaging systems and conducted food illness investigations, including botulism outbreaks.

Since 2006 Mr. Nelson has been an independent consultant to the food industry. He is an expert in LACF and other food safety issues. He has spoken on food safety controls in China and other countries and conducted numerous mock FDA food safety inspections throughout the world. He is available to assist EAS clients establish their food safety programs and to investigate food borne outbreaks.

He received his Bachelors of Science in Human Biology in 1975 and his Masters of Science in Environmental Toxicology in 1991 from the University of Wisconsin, Green Bay. Mr. Nelson is professional member of the Institute for Thermal Processing Specialists.

Joseph Ouellette

Joseph Ouellette is a strong Quality Leader with progressively responsible experience in the medical device field implementing and maintaining GMP, GLP and ISO compliant quality systems.

He was President of Custom Microbiology Associates, a leading a consulting firm providing competent direction and guidance to medical device clients in support of their goal to comply in all aspects of domestic and international quality and regulatory regulations including FDA (QSR), Medical Device Directive (93/42/EEC) and Canadian Medical Device Regulations (CMDR) as well as international standards ISO 13485, ISO 14971, IEC 60601.

Prior to that he worked for Philips Medical Systems providing strategic leadership and set policies for quality and regulatory standards, assuring that the Quality System is compliant with FDA (QSR) and applicable regulatory standards such as MDD 93/42/EEC, ISO 13485, FCC, RTTE, and EMC requirements in addition to company and divisional quality system requirements. He monitored and interpreted new regulations and industry trends, providing strategic direction to Executive Management to proactively ensure that New Ventures products and operations are at the forefront of quality and compliance regulations. He also developed and maintained collaborative relationships with key personnel in external regulatory agencies, fellow quality professional colleagues and internal support resources

He also worked for Becton and Dickinson Ophthalmic Systems as Manager of Quality Assurance and Regulatory Affairs. Regulatory activities including 510(k) submissions, foreign country product registrations and product device master records and EU MDD technical file maintenance. It also included regulatory compliance such GMP maintenance to FDA (QSR), MDD and EN 46001 requirements, complaint system to domestic FDA (MDR's) and European vigilance requirements.

Joseph holds a M.S in Medical Lab Science from Northeastern University and a BS in Microbiology from University of Massachusetts. He is a Certified Quality Engineer (CQE), Certified Quality Manager (CQM) and a trained ISO-9000 auditor.

David K. Park, EAS Senior Consultant

David K. Park joined the EAS team in April 2008. Mr. Park is an internationally recognized expert in thermal processing. He is also an expert in food safety and defense, specializing in improving processes, procedures and policies in order to defend a company's brand and business.

Early in his career, he was head of the process engineering section of the National Canners Association, which has since evolved into the Grocery Manufacturers Association. After eight years with the canning group, he joined TechniCAL, Inc., a thermal process consulting firm in New Orleans, La., as Technical Director. He later served as Technical Fellow at the FMC FoodTech, Food Processing Systems Division in Madera, Calif.

Mr. Park left FMC FoodTech in 2001 to become an independent food safety and food defense consultant. He still serves as a vice-president of TechniCAL, where he directs their thermal processing authority program.

Mr. Park has served as an Institute of Food Technologists Distinguished Lecturer and he currently lectures on thermal processing certification subjects at FDA/USDA Better Process Control Schools. He also holds a special-term appointment with Argonne National Laboratory in Argonne, IL. as an infrastructure assurance analyst helping to support government and industry preparedness in food defense. He holds a DOE Top Secret security clearance.

Salvatore J. Pinella – Senior Consultant

EAS is pleased to offer the services of Sal Pinella to our pharmaceutical clients.

Mr. Pinella has over 52 years of pharmaceutical experience which focused on an expertise in both Regulatory and Scientific Affairs. His 29 years of experience in FDA included positions as: a Scientific Coordinator, Division of Field Science; Review Chemist responsible for the review and evaluation of NDAs, DMFS, and INDs in CDER; and, a Compliance Officer and Analytical Chemist at FDA's New York District Office.

Upon retirement from the FDA in 1986 until January 2003 he served as a consultant to the pharmaceutical industry as a sole proprietor/outside contractor. From January 2003 to 2009 he has served as a Senior Regulatory Consultant to AAC Consulting Group, Kendle Regulatory Affairs. In this position he has conducted both international and domestic inspections of pharmaceutical companies to determine their compliance to cGMP Regulations, and prepared and edited Applications (INDs, CTAs, ANDAs NDAs, DMFs, and IMPDs in CTD and non-CTD format).

Mr. Pinella joined EAS as a contract consultant in January 2009. If you need assistance with submitting data to support the approval of a drug application or have questions on other drug regulatory/scientific matters, give us a call.

Roger Rand - Senior Consultant

Mr. Rand has an extensive industry background. His 27 year career includes 21 years in FDA-regulated industries (16 of those were in medical devices) with such companies as Becton Dickinson, BSN Medical, and Gillette.

During his career he was a Quality Engineer (ASQ Certified Quality Engineer for 24 years), Quality Control Manager, Quality Engineering Manager, Division Quality Assurance Manager, Quality Assurance and Regulatory Affairs Director, and Corporate Global Quality Systems Director.

His last position, prior to becoming a Consultant, was as Corporate Global Quality Systems Director. In that role he focused on FDA compliance for medical device plants around the world to assure their conformance to FDA requirements.

During his career, Mr. Rand was assigned the task of following-up on Warning Letters and 483s for multiple plant locations. He also consulted on Corrective Action Remediation under a Consent Decree. He has managed and built (quality engineering/control/assurance, regulatory affairs, document control and complaint handling) compliant systems through the evolution of GMPs to cGMPs to QSR, the European Medical Device Directive, and ISO 13485. His experience gives him the ability to quickly discover compliance gaps in systems, and to help with effective and efficient corrective action.

Roger Rand joined EAS as a Senior Consultant, on a contract basis, in August 2007 and is available to help medical device firms with cGMP compliance.

Kim A. Rice

Mr. Rice has over 33 years of FDA and consulting experience for EAS clients looking for assistance especially with dietary supplement and pharmaceutical regulatory and compliance needs. He served 33 years with FDA in various investigative positions before becoming an independent consultant in 2009.

Mr. Rice began his FDA career in 1976 as an Investigator in the Minneapolis District Office. He conducted inspections in a broad range of FDA regulated products and specialized in the pharmaceutical area. His next assignment was to establish the Resident Post in Pocatello, ID, where he served as its Resident in Charge. In this capacity he handled all inspectional work in Eastern Idaho and worked extensively with state and local officials. He then transferred to the Seattle District Office where he worked as specialist for 5 years conducting inspections regarding pharmaceuticals, dietary supplements, biologics and in-vitro diagnostics. He also developed an expertise in the new molecular techniques being developed and became the Regional Biotechnology Specialist.

For 5 years he worked as a Supervisory Investigator in the Seattle District Office. During this time he was responsible for the oversight of Investigators and Engineers conducting inspections and investigations in a wide variety of program areas under FDA purview. He had responsibility for supervising import operations as well as oversight of the medical device, drug and biologics programs.

Upon the creation of FDA's Office of Criminal Investigations Mr. Rice transferred into this new unit where he served in increasingly responsible headquarters and field positions including over 7 years as the Special Agent-in-Charge of the Washington Field Office. In this position he successfully managed a wide variety of noteworthy and impactful FDA criminal investigations. He also worked closely with the various FDA Centers and participated in numerous agency working groups and task forces regarding medical device issues, drug post market safety matters, counterfeit drugs and application integrity.

Mr. Rice has a strong training background to include many years of experience instructing at FDA's national Evidence Development Training Program which all new FDA Investigators must attend. He has also developed FDA training programs and prepared inspectional guidance for field investigators. He has spoken frequently to the pharmaceutical industry on FDA enforcement issues.

Mr. Rice joined EAS in 2010 and is available to conduct audits of dietary supplement and pharmaceutical firms. In addition he can assist you with supply chain and product security matters. He can also develop and provide training on matters related to FDA regulatory requirements.

Fredric Richman

Fredric Richman is an FDA-veteran in pharmaceutical regulatory affairs. He has served as an Investigator, Compliance Officer, Case — Reviewer and Director for Division of Compliance for Office of Regulatory Affairs.

As Director he managed a division of consumer safety officers and support staff engaged in three regulatory activities: (1) the review and clearance of legal and administrative sanctions recommended by the field district offices (2) the review of reports of violative inspectional findings for Team Biologics inspections (covering vaccines and therapeutic biologics) and recommending appropriate regulatory actions to the Center for Biologics Evaluation and Research and (3) provide agency-wide oversight to field and center recall activities. He applied risk-based principles in identifying firms for regulatory attention and cases warranting expenditure of limited agency resources. He also conducted regulatory meetings with top corporate officials representing firms that were the subject of warning letters or other contemplated regulatory actions.

As Associate Director he supervised regulatory operations of the New Drugs and Labeling Team (Prescription Drugs), OTC Drugs Team, the Imports and Exports Team, the Internet and Health Fraud Team, and the Compounding Team. He was responsible for evaluating evidence of possible violations of the Federal Food, Drug, and Cosmetic Act and related regulations and initiating appropriate legal and administrative sanctions. This included developing cases against pharmacies engaged in the illegal dispensing/shipping of unapproved drugs from Canada. He provided management oversight for 26 professionals (consumer safety officers and U.S. PHS Commissioned Corps Officers/pharmacists). Using risk based considerations, initiated the development of a revised compliance policy guide on unapproved new drugs, including developing a regulatory strategy to address so-called DESI final and other categories of drugs within the spectrum of marketed unapproved new drugs.

Mr. Richman holds a B.A in Chemistry from Queens College of City University of New York and an M.S in Chemistry from St. John's University.

Karin Ricker

Dr. Ricker joined EAS Consulting in 2010. A native of Germany, Dr. Ricker has over 17 years of professional experience working as a regulatory scientist, including over 7 years at the Food and Drug Administration. Dr. Ricker worked in FDA's GRAS and Biotechnology Program, in the Office of Food Additive Safety, Center for Food Safety and Applied Nutrition. In her capacity as Consumer Safety Officer, Dr. Ricker handled and reviewed a wide variety of industry submissions to FDA's GRAS and Plant Biotechnology programs and answered hundreds of questions on FDA's food ingredient safety and regulations. Dr. Ricker can assist EAS's clients with determining the regulatory status of new food ingredients; answer regulatory questions, and can help prepare and/or review your firm's GRAS and biotechnology notifications. Dr. Ricker is also available to educate non-US clients on regulations governing food ingredient safety for the U.S. market; and to assist non-English speaking clients with a review of their firm's submissions for required formats, appropriate use of scientific and regulatory English terminology, completeness, and regulatory issues.

William L. (Bill) Schwemer, Senior Consultant

With 45 years experience with government, industry and a professional organization, Mr. Schwemer is well prepared to provide assistance in interpreting FDA policy in domestic and international matters, building quality systems, evaluating compliance with FDA Current Good Manufacturing Practices Regulations, and developing regulatory strategies.

After Mr. Schwemer received a Bachelor of Science degree in Chemistry from Bowling Green State University, Bowling Green, Ohio in 1962, he began his FDA career as an Investigator in Detroit District. He held field positions of Resident Investigator, Supervisor and Compliance Officer prior to transferring to FDA headquarters as Assistant to the Director of the Compliance Coordination and Policy Staff in the Office of the Commissioner. In this staff position he was responsible for reviewing controversial or precedent setting legal action recommendations by agency offices and centers and recommending disposition decisions by the Associate Commissioner or Commissioner.

Senior FDA positions in which Mr. Schwemer served include Director of the Division of Field Investigations, Assistant Associate Commissioner for Regulatory Affairs, and Special Assistant to the Deputy Commissioner for Policy. From July 1993 through January 2003, as a Senior Consultant with AAC Consulting Group/Kendle, he provided advice to clients domestically and in 10 countries on matters within the purview of the FDA. While with AAC, he co-authored and performed the technical edit of the text Application of Pharmaceutical GMPs, Food and Drug Law Institute (Washington, DC 1997). He wrote 18 articles on regulatory and enforcement issues that were published in editorial board or peer reviewed publications and over 100 that were published in AAC’s in-house publications. He has participated in a number of conferences and training programs as a lecturer on matters dealing with FDA regulations, including quality assurance, bioresearch monitoring, and enforcement.

In 2003, Mr. Schwemer became Vice President of Quality Assurance and Regulatory Affairs at a contract manufacturer of personal care items including non-prescription drugs. In that position he had direct responsibility for quality assurance, laboratory operations, and regulatory matters including compliance with FDA, safety and environmental rules. He developed and implemented an ISO based Quality System that incorporated GMPs for pharmaceuticals.

Mr. Schwemer has been retained as an expert witness in 17 lawsuits involving civil disputes related to foods, drugs, medical devices and biologics and has testified at depositions and jury trials. He continues to be a member of the Association of Food and Drug Officials and RAPS. He is Regulatory Affairs Certified and has received certificates for completing ISO-9000 lead assessor and Hazard Analysis and Critical Control Point (“HACCP”) training.

Norma Skolnik – Senior Consultant

If you are seeking regulatory advice from someone who has many years of first-hand industry experience you will want to speak with Norma Skolnik. Norma joined EAS as a contract consultant in January 2008.

Norma Skolnik has 30 years of regulatory experience in the Food, Dietary Supplement and OTC drug industries. She has had extensive experience advising on regulatory strategies for new and marketed products, particularly regarding the development and review of optimal product claims and advertising. In addition to her knowledge of U.S. FDA regulations, Norma has worked extensively on Latin American and Canadian regulatory issues as well as matters related to U.S. Food imports and Bioterrorism regulations.  She is familiar with regulatory trends throughout the Americas.  Norma has been involved with the implementation of recent FDA Food Safety and Import Safety programs and has experience resolving regulatory import issues.

Norma has had broad experience providing regulatory guidance for new and marketed OTC drugs including claims development and advertising review. She’s helped launch numerous products in the dietary supplement and functional food area. She has implemented adverse event reporting programs for dietary supplements and OTC drug products, including implementation of new FDA Serious Adverse Event Reporting requirements.

For the past 10 years, Norma has served as Director of Regulatory Affairs for Cadbury Adams Americas (formerly Adams Division of Pfizer). Previously she was Associate Director of Regulatory Affairs at Wyeth Consumer Healthcare and Associate Director, Regulatory Affairs, at Lederle Consumer Health division of American Cyanamid.

Robert Snell – Senior Consultant

Mr. Snell retired after 42 years with FDA and accepted a position as a contract consultant with AAC Consulting Group, Inc. The assignments consisted of auditing the manufacturing, laboratory, and compliance sections for pharmaceutical firms, reviewing, evaluating, and recommending changes to the analytical section of NDA's, compiling the CMC section of NDA's, reviewing out-of-specification laboratory results and determining if the investigation complied with FDA requirements as specified in guidance documents, reviewing and determining the adequacy of investigations generated by manufacturing to explain problems encountered during the manufacturing of a drug product, evaluating and revising manufacturing and laboratory SOP's, and evaluating the overall compliance of a firm's compliance with 21 CFR 210 & 211.

Mr. Snell was a compliance officer the last 7 years with FDA The majority of his work was in the drug area; both human and animal. If regulatory action was indicated, Mr. Snell submitted a written recommendation to the appropriate Center. The recommendation cited the regulations that were violated and related these violations to the Act. All cases were managed to conclusion. In addition, he also reviewed food and dietary supplement labels and labeling. Other duties included directing investigators in drug inspections and participating in the investigations.

As a research chemist with the agency, Mr. Snell identified and developed analytical procedures for chemicals leached for medical devices, namely those devices composed of materials containing phthalates. The methods used packed and capillary gas chromatography, gas chromatography/mass spectrometry, high pressure chromatography, infrared, visible, and ultraviolet spectrometry, and thin layer chromatography. The research resulted in several papers published in peer reviewed journals and several papers presented at national symposia.

Mr. Snell's other positions with FDA were as a supervisory chemist and a bench chemist. He directed and performed the full range of analyses performed in FDA field laboratories. The samples consisted of foods for composition, filth, residues, decomposition, and trace metals; drugs for active ingredients, degradation products, dissolution, and release profiles; medicated feeds for active ingredients; color analysis in cosmetics. As a supervisory chemist, he developed and directed the quality control procedures used in his laboratory and reviewed all work before it left the laboratory.

If your firm is looking for a consultant with a broad range of FDA experience, Mr. Snell is the individual you want on your team. Mr. Snell Joined EAS as a contract consultant in March, 2008.

Jeffrey B. Springer – Senior Consultant

Jeffrey Springer offers your company his 33 years of experience as an Attorney in the Office of the Chief Counsel of the FDA. He provides clients with a wide-range of regulatory consulting services. He is especially forthcoming with advice and assistance on compliance matters and strategy. With his background in managing legal reviews and litigation, and clearing the FDA’s regulations, Mr. Springer will be a valuable asset to your project team.

Mr. Springer received his law degree in 1968 from the Georgetown University Law Center. He immediately became a Trial Attorney for the FDA, representing the Agency in civil and criminal enforcement cases in court. He also represented the FDA in defensive and appellate litigation in court. From this position, he became the Special Assistant to the Chief Counsel where he assisted with law office management, resolved problems with staff employees and was responsible for special projects. In 1975 he became the Deputy for Regulations and Hearings. This position required him to manage the legal review and clearance of Agency regulations, the program review services, and administrative hearings. He became the Deputy Chief Counsel in 1979, a position he held for 20 years. In that position Mr. Springer assisted the Chief Counsel with internal management, provided legal service and advice to high-ranking FDA officials, represented the FDA in functions involving other federal agencies, and improved the process of reviewing proposed legal and regulatory actions. His final role at the FDA was as a Senior Advisor to the Chief Counsel. While there he provided consultant advice, assistance, and services concerning operations and management. He was responsible for the law office redesign and reorganization, and managed the attorney recruitment and selection program. Mr. Springer received numerous awards in his time with the FDA, such as the Commissioner’s Special Citation in 1989 and 1999. He is also a member of the District of Columbia Bar Association.

Mr. Springer joined EAS Consulting Group as a Contract Consultant in 2006. You will find his legal background and FDA experience to be invaluable.

James L. Summers – Senior Consultant

James Summers “wrote the book on food and dietary supplement labeling”. He is the author of valuable reference books that provide a comprehensive guide designed to aid in understanding FDA labeling requirements as they apply to foods and dietary supplements. He is a 32-year veteran of FDA, with an additional 10 years of labeling consulting experience.

At FDA he held positions as Aquatic Sampling Specialist, Supervisory Microbiologist, Public Health Sanitarian, General Biologist, FDA Inspector, Regional Shellfish Specialist, and Consumer Safety Officer (Division of Regulatory Guidance). His last position with the FDA was as Supervisory Consumer Safety Officer, Branch Chief in the Office of Food Labeling. There he handled the most controversial and precedent-setting problems involving regulatory compliance issues dealing with food labeling. He participated in the development of policies and regulatory strategies regarding the enforcement of NLEA and other food labeling regulations.

During the 10 years following his government service he was a Senior Consultant for AAC/Kendle. He has reviewed labels for AAC clients and provided them with an “insiders” perspective on FDA labeling regulations and enforcements policy. He also served as an instructor in the popular labeling seminars offered to AAC clients.

In October 2006 Mr. Summers joined EAS Consulting Group as a Contract Consultant. He is available to assist in reviewing labels for FDA compliance, and to conduct labeling seminars for the food and dietary supplement industries.

Stanley M. Tarka, Ph.D. - Senior Consultant

Holding a doctorate degree in food science, emphasizing toxicology, Dr. Stanley Tarka is an expert in food regulations who spent 28 years at the Hershey Foods Corporation. He has extensive experience in the basic and applied research and development of food ingredients, processes, and consumer brands, as well as the regulations governing them. For 3 years prior to joining EAS as a contract consultant, Dr. Tarka provided consulting assistance to AAC/Kendle. For your next food or nutrition project, his expertise may be exactly what you are looking for.

Dr. Tarka began his career as an Analytical Biochemist at the Velsicol Chemical Corporation, where he was involved in research and the metabolic screening of potentially new products. He joined the Hershey Corporation in 1974 as a Supervisor in Animal Research responsible for conducting all corporate nutritional and toxicological research. He became a Group Leader in Nutritional Sciences, involving monitoring regulatory affairs, evaluating the nutritional quality of products, evaluating the effects of processing on nutritive value, and doing detailed toxicological evaluation of naturally occurring alkaloids in cocoa. He then held a number of roles, such as the Director of Food Science and Nutrition, where he was responsible for all research activities in analytical research, laboratory services, microbiology research, nutrition research, biochemistry research, biotechnology, toxicology, nutrition affairs, ingredients research, and process research. His final role at Hershey was as the Senior Director of Food Science and Technology where he was responsible for all basic and applied R&D and support of product development, product improvements, and new ingredients.

In 2002 he founded The Tarka Group of scientific and regulatory consultants who provide expert scientific and regulatory consultation to food, nutrition, beverage, chemical, and pharmaceutical companies. Dr. Tarka has written a number of abstracts and articles, and he is also the co-owner of six patents relating to ingredients and processes. He is a member of many organizations including the Society of Toxicology, American College of Toxicology, the American Society for Nutritional Sciences, and the American Society for Pharmacology and Experimental Therapeutics, and he serves as a member of the FAO/WHO Expert Committee on Food Additives.

EAS Consulting Group is pleased to offer Dr. Tarka’s services as a Senior Consultant for your company. He is available for safety assessments of ingredients, new product design and execution, R&D of new products, critical reviews and strategies for ingredient usage and approval, expert testimony, expert panels for GRAS assessments, self-GRAS reviews, health claims and qualified health claim petitions, and design and management of clinical trials. If you have a new food product to develop, Dr. Tarka is who you are looking for.

John A. Thomas

Dr. John A. Thomas was born and educated in the Midwest. He received his undergraduate degree at the University of Wisconsin-LaCrosse and his M.A. and Ph.D. degrees at the University of Iowa.

He has held professorships in departments of pharmacology and toxicology in several medical schools including Iowa, Virginia and West Virginia. Professor Thomas has been the mentor for many doctoral students and has trained several post-doctorals. From 1973 to 1982 he served as Associate Dean of the School of Medicine at West Virginia University where his responsibilities included graduate programs and research. In 1982, Dr. Thomas moved into the healthcare industry where he became Vice President for Corporate Research at Baxter Healthcare. While in industry, he was involved in new drug development including recombinant DNA-derived therapeutic agents. Dr. Thomas served as Vice President at the University of Texas Health Science Center at San Antonio from 1988-1998. He is the author of over a dozen textbooks and research monographs and has published nearly 450 scientific articles in the area of endocrine pharmacology and reproductive toxicology. He is a member of numerous societies including the Endocrine Society, the Teratology Society, American Society for Pharmacology and Experimental Therapeutics, Society of Toxicology, and the American College of Toxicology. Professor Thomas serves on several editorial boards of biomedical journals and has been a member of the National Library of Medicine Literature Selection Technical Review Committee. Dr. Thomas served as a Specialty Editor for Toxicology and Applied Pharmacology, and is on the Editorial Board of Food and Chemical Toxicology. He served on the Air Force Science Advisory Board. He has been a member of the Institute of Medicine/National Academy of Science Committee on Micronutrients, and is past-Chairman of the Expert Advisory Committee of the Canadian Network of Toxicology Centers.

He was a member of the FDA Science Advisory Board as well as a member of other FDA Review Committees for the NCTR, NARMs and ORA. He is the recipient of the FDA Commissioner's Special Citation Award and the FDA's Advisory Committee Distinquished Service Award. Dr. Thomas served as Chairman of the NTP/NIEHS, Center for Evaluation of Risk to Human Reproduction, Expert Panel on Ethylene and Propylene Glycol as well as being a member of the Expert Panel on soy infant formula and genistein.

Dr. Thomas is a Diplomat and Fellow in the Academy of Toxicological Sciences as well as a Fellow in the American College of Toxicology. He continues to serve on many scientific boards and committees in the chemical and pharmaceutical industry. He served as Vice President for the Texas Society for Biomedical Research, as a member of the Board of Trustees of the International Life Sciences Institute and on the Board of Directors of the Academy of Toxicological Sciences. Dr. Thomas is Past-President of the Academy of Toxicological Sciences. He was named the 1999 recipient of the Distinguished Service Award from the American College of Toxicology. Dr. Thomas is Past-President of the American College of Toxicology. He is the recipient of several national awards including the Merit Award from the Society of Toxicology, Certificate of Scientific Service (U.S.E.P.A.), Distinguished Lecturer in Medical Sciences (A.M.A.), andDistinguished Service Award from the Texas Society for Biomedical Research, and holds Distinguished Alumni Awards from both the University of Wisconsin-LaCrosse and the University of Iowa. He is an elected foreign member and Fellow of the Russian Academy of Medical Sciences.

Freddy Vaede, Ph.D. - Senior Consultant

Located in the Paris, France area, Dr. Freddy Vaede has 35 years of experience working with multinational pharmaceutical companies. He has an Industrial Pharmacist background from Paris University with a specialization in Analytical Chemistry. For 15 years, Dr. Vaede was the Head of Quality at two dosage form manufacturing sites ICI-Pharma now Astra-Zeneca, and Rhône-Poulenc now Sanofi-Aventis. He also served in corporate positions in the Quality Department of Rhône-Poulenc Rorer, Aventis, and Sanofi-Aventis. His last position in Sanofi-Aventis was Director of Strategic Support in their Corporate Quality Department.

During his long career, Dr. Vaede developed his competency and expertise in GMP and Quality matters on Active Pharmaceutical Ingredients (ICH Q7A) and Dosage Forms (21CFR parts 210 & 211 and European GMPs). He specialized in supporting GMP manufacturing sites located in Europe and Asia (India, China, Japan, and Singapore). He assisted them at the shop-floor level in their preparation for FDA and European Authorities Inspections, and in managing these inspections where needed as a facilitator. With his support, successful results were achieved on the inspections.

Dr. Freddy Vaede has participated actively in the preparation of Corporate Quality and GMP Guidelines/Standards for Rhône-Poulenc Rorer, Aventis, and Sanofi-Aventis. Among his other responsibilities he was in charge of many of the audits performed in APIs, Dosage Forms, and Sub-contractors' manufacturing sites located worldwide—Europe, Asia, and the USA. He was also responsible for managing quality risks for APIs from biological origins (Heparins and others) such as viral safety, BSE, etc.

Dr. Vaede was a Qualified Person in the Rhône-Poulenc Group, an Analytical Expert for French Health Ministry, and is a Certified APIC Auditor.

If you need an expert in GMP and Quality matters for audits, assessments, and support for APIs and Dosage Form sites located worldwide (particularly in Europe and Asia). Dr. Vaede is the Senior Consultant that will satisfy your expectations.

Dr. Vaede joined EAS as a Contract Consultant in June 2008.

Michael Van Duncan

If you are looking for an nationally recognized expert in Meat, Poultry, and Egg Products, HACCP, and SSOP's with 36 years of USDA experience and almost a year of consulting experience, you will be pleased to know that Michael Duncan is available to assist your firm develop and implement HACCP controls.

Mr. Duncan joined EAS in December 2008 as a Contract Consultant after having worked for USDA and FSIS. He has 21 years of inspection experience working for the FSIA as a Compliance Officer/Investigator Officer within the States of Alabama and Mississippi. Among other responsibilities, Mr. Duncan worked on special projects related to the certification of State inspection programs, labeling, investigative techniques, and supervising other Compliance Officers. He conducted reviews of processing plants, freezers, and grocery warehouses and distributors. His experience includes 15 years of processed meats, canning, curing, sausage formulation and boning.

Mr. Duncan is available to conduct HAACP audits, write HAACP plans and assist in HAACP training for meat, poultry, and egg producers.

Virginia L. Wilkening, R.D., M.S. – Senior Consultant

EAS Consulting Group is pleased to offer the services of Virginia Wilkening, a veteran Nutritionist with 34 years of combined Food and Drug Administration (FDA) and U.S. Department of Agriculture experience (USDA).

Ms. Wilkening joined the FDA in 1983 and retired from the Agency in April 2004. The last position she held there was Deputy Director, Office of Nutritional Products, Labeling, and Dietary Supplements (ONPLDS) in the Center for Food Safety and Applied Nutrition (CFSAN). As Deputy Director, Ms. Wilkening shared responsibility for developing policy and regulations for dietary supplements, nutrition labeling, food standards, infant formula, and medical foods as well as for compliance/enforcement actions and scientific evaluation to support such regulations and related policy development, and analytical database research. Prior to this position, she served as Team Leader for a multi-disciplinary group responsible for implementing that part of the Nutrition Labeling and Education Act of 1990 that pertained to nutrition labeling, Reference Daily Intakes (RDIs), Daily Reference Values (DRVs), serving sizes, and format for the nutrition label. She had a similar role in implementing the Dietary Supplement Health and Education Act of 1994.

She worked for 12 years as a Nutritionist with the Nutrition and Technical Services Staff in the Food and Nutrition Service, USDA. Her work included developing nutrition standards and goals, and evaluating the effectiveness of such goals for the National School Lunch Program and other child nutrition programs. She also worked as Chief Dietitian at Mather Memorial Hospital in Port Jefferson, New York for 5 years.

Ms. Wilkening earned her Master of Science degree in Nutrition at the University of California in Davis, California. She attended a Dietetic Internship at Grasslands Hospital (now part of New York Medical Center) in Valhalla, New York. Her Bachelor of Science degree is also from the University of California at Davis with a major in Nutrition and Dietetics.

Awards given to Ms. Wilkening include the 1994 Dietitian of the Year Award for the U.S. Public Health Service, the Department of Health and Human Services’ Superior Service Award in 1993, and upon retirement, a CFSAN Legacy Award and the FDA Distinguished Career Service Award.

Ms. Wilkening joined EAS as a Senior Consultant on a contract basis in January 2007.

John Yount

John Yount began his 34-year FDA career as an inspector and advanced to become assistant regional director for FDA's Southwest District. Prior to that role, he was director of investigations in the Denver District office and served as a supervisory investigator and investigator for several years. He held special credentials for clinical investigations and had extensive experience in all industries regulated by FDA. In addition, he served as a trainer for several of the agency's national training programs, including courses on law and evidence development for FDA investigators and HACCP. He held 200C credentials (special training for clinical investigations), and had extensive experienced in all industries regulated by FDA.

After leaving the agency in 1998, he joined AAC/Kendle as a senior consultant. Since 2005, he has been with J&L Pharmaceutical Consulting. His work as a consultant focused in the area of auditing and training. The major portion of his audits has been in the pharmaceutical arena, and has included work in the areas of Good Clinical Practices, Good Manufacturing Practices (for finished dosage form as well as active pharmaceuticals), and Good Laboratory Procedures. He has conducted many audits covering the production of sterile APIs and sterile finished dosage form drugs, vaccines and blood products.

John was lived in the UK for two years and has direct experience in the auditing of vaccine productions facilities in the European continent. This includes audits of adenoviral vaccine intermediates for phase I, and II clinical studies, recombinant MVA (Modified Vaccine Ankara Virus) and retroviral vectors. He also has direct experience in the auditing of blood fractionation in the UK. He has a significant amount of experience in conducting audits of plants producing medical gas by air separation and by chemical production. He was the author of many articles on the subjects of FDA regulations, programs, and policies for the FDA News and Information published by then the AAC Consulting Group.