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.

Carl Reynolds – Vice President

EAS Consulting Group has one of the country’s premier food experts in Carl Reynolds. With 44 years of FDA and consulting experience, he genuinely is a food regulatory compliance expert. His combination of 36 years with FDA and 7 years with AAC/Kendle has provided him a broad experience and knowledge base. He has extensive domestic and international experience in managing and investigating microbiological food safety concerns, policy development and implementation, and training activities. He is a specialist in the area of food safety, dietary supplements good manufacturing practices and low acid and acidified canned foods. He was considered as one of the early FDA experts in Hazard Analysis and Critical Control Point (HACCP) implementation.

Mr. Reynolds’ career began in 1962 as an Investigator in FDA’s Denver District where he conducted inspections and sample collections in all of the product areas regulated by the FDA. He next served as Resident in Charge in the FDA’s Albuquerque Resident Post where he also did training, testified in legal proceedings, and provided sworn statements in court depositions. He served 5 years as a Supervisory Investigator in the Dallas District, 11 years as the Director of the Investigations Branch in the Orlando District, and 5 years as the Detroit District Director. In these positions he managed staff assigned to investigative/ inspectional, compliance, research, and regulatory laboratory activities. He also reviewed legal recommendations, developed enforcement strategies, and directed a comprehensive import program.

His final role at the FDA was as the Director of the Office of Field Programs at the Center for Food Safety and Applied Nutrition (CFSAN). His staff was responsible for health hazard classification, level of effectiveness checks, and media coverage regarding recalls of food products. He was the Center contact for all food borne illness emergencies and outbreaks, and represented the FDA and CFSAN at both international and domestic meetings and training events. He is a member of the Association of Food and Drug Officials and was a former member of the U.S. delegation to the Codex Committee on Import and Export Food Inspection and Certification Systems.

Mr. Reynolds joined AAC/Kendle as a Senior Consultant in 1999. He conducted comprehensive audits of food manufacturing and warehousing facilities and dietary supplement manufacturers. He is an approved auditor by the Natural Products Association (NPA) for conducting audits of dietary supplement manufacturers. He has testified in Federal Court and provided dispositions in food safety and dietary supplement cGMP regulatory issues. He has been accepted during trial as an expert in the areas of food safety, and the inspection authorities and activities of the FDA as well as implementation of the Federal Food, Drug, and Cosmetic Act. Let his extensive regulatory expertise work for your company.

In October 2006 Mr. Reynolds became a Vice President of EAS Consulting Group.

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.

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.

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.

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.

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.

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.

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.

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.

George H. Pauli, Ph.D. - Senior Consultant

If you need an expert in food additive regulations with nearly 29 years of FDA experience, you need George Pauli. Dr. Pauli retired from FDA as the Associate Director for Science and Policy, Office of Food Additive Safety, CFSAN in March 2006. In 2004 he served as Acting Director of the Office of Food Additive Safety for an extended period. He joined AAC/Kendle as a contract consultant in 2006 and is now available to share his knowledge and experience with EAS Consulting Group clients.

Dr. Pauli began his FDA career in 1977 as a Consumer Safety Officer in the Petition Control Branch of the Division of Food and Color Additives, working mainly on indirect additive petitions, food irradiation, and the cyclic review of food additives. In 1981 he was named a Supervisor and oversaw decisions on several color additive regulations, as well as indirect additive regulations and irradiated food regulations. At that time he directed development of the first decisions implementing FDA’s carcinogenic constituent’s policy. In 1985 he was named head of the Food Additive Policy Staff, a group created to work on difficult or unprecedented issues. In 1990 he was named Chief of the newly created Novel Ingredients and Biotechnology Branch where he recruited new Consumer Safety Officers for the Division of Food and Color Additives, and oversaw development of documents regarding emerging issues such as genetically engineered plants and novel ingredients, including olestra.

Following a Center for Food Safety and Applied Nutrition reorganization in 1992, he became Director of the Division of Product Policy, the organization responsible for genetically engineered foods and other issues where policy had not yet been established. In this role, he headed efforts at reinventing government by replacing the GRAS petition and regulation process with a notification process and by establishing a formal collaborative process with the Food Safety and Inspection Service to coordinate decisions on food ingredients added to meat and poultry products.

Dr. Pauli has received numerous awards during his career including the FDA Award of Merit, the Agency’s highest honor. He has served on expert panels for the World Health Organization and the International Atomic Energy Agency regarding irradiation of foods.

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.

Thomas L. Schwarz – Senior Consultant

A 30-year government veteran, Thomas Schwarz spent most of his professional career with FDA. He graduated from college with a chemistry degree and went on to obtain a Masters Degree in Entomology from North Carolina State University. He offers EAS clients a broad range of services that draws upon his extensive food safety experience.

After starting his government career in 1970 as a Plant Quarantine Inspector for USDA, he became an Entomologist examining foods for insect contamination for FDA’s New York District Laboratory. He then moved to FDA headquarters where he spent 26 years in various positions of increasing responsibility in the Center of Food Safety and Applied Nutrition (CFSAN). These positions included working as a Program Analyst writing Compliance Programs, serving as a Sanitarian/Consumer Safety Officer in the Division of Cooperative Programs, and a Science Policy Analyst in the Executive Operations Staff. He was the Center Director’s technical expert and consultant on microbiological issues including E. coli O157:H7, Vibrio cholerae, Listeria monocytogenes, and Salmonellae. He coordinated FDA activities with CDC following the outbreak of Eosinophilia Myalgia Syndrome attributed to consumption of L-tryptophan.

From 1990 to 1995, Mr Schwarz was the Director of the Division of Cooperative Programs where he was responsible for a staff of 23 professionals in the retail food, interstate travel, milk safety, and shellfish programs. In that capacity he interacted with consumer groups, industry trade representatives, government officials (federal, state, and foreign), professional associations, and academia concerning public health issues. He served as FDA’s liaison to the Executive Board of the Conference for Food Protection, and as the Agency’s spokesman to CFP’s Council III (Science and Technology). He was responsible for mentoring the development of HACCP guidance for retail establishments.

Before retiring from government service in 2000 to become an independent Food Safety Consultant, Mr. Schwarz served as Special Assistant to the Deputy Director, Food Safety Initiative Staff, CFSAN. There he was a member of a team working on special projects on making imported foods, especially fresh produce, safer for American consumers. He holds memberships in numerous professional associations and is the recipient of 14 FDA Performance or Special Service Awards

Mr. Schwarz joined EAS as a Contact Consultant in December 2006.

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 Dug 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.

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.

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.