Issue of the Month
FDA’s Enforcement Priorities for 2012

by EAS Senior Consultant Joe Baca

Changes at the Food and Drug Administration and especially in its Office of Regulatory Affairs (ORA) will help to transform the agency from a domestic to a global regulator. FDA’s Principal Deputy Associate Commissioner for Regulatory Affairs, Howard Sklamberg, discussed ORA’s enforcement priorities for fiscal year 2012, in a December 6 presentation at the FDLI Enforcement, Litigation and Compliance Conference in Washington, D.C.

The overall enforcement strategy will be to prevent public emergencies before they happen. This will include “earlier prevention” as the agency moves quickly to investigate situations in which there are “noncomformities or signals,” he said. It will also include “earliest prevention” using systems that safeguard against economic fraud, negligent production and theft, he said.

Mr. Sklamberg cited some numbers that may be familiar to many readers, notably the dramatic increase in FDA-regulated imports over recent years—including about 10 percent per year for foods, almost 13 percent per year for pharmaceutical products and more than 20 percent for medical devices. FDA-regulated imports could triple between 2007 and 2015, he said.

I was interested to see Mr. Sklamberg refer to the investigative skills of FDA’s “cross-trained workforce.” Previously, we saw a shift by the agency away from generalists and toward specialization. Since the early 1990’s, new hires were not trained in the regulation of all FDA-regulated commodities, but were expected to specialize in one or two product areas. It was in ORA’s network of resident posts that knowledge of a broad range of FDA regulated commodities was more likely to be found. But as the agency has responded to emergencies in the past few years, many of them food related, the ability to work across a variety of commodity areas has once again become an asset for managers and employees. It’s encouraging to see that top ORA management recognizes a cross-trained workforce as a strength. Hopefully, this will encourage employees to diversify their knowledge base.

Hiring Paradox

The significant increase in foreign food inspections mandated by the Food Safety Modernization Act will impose a huge burden on FDA in 2012 and beyond. Assuming that the agency is given the resources to accomplish the ambitious goal, it will have to resolve what I call the hiring paradox. In the first year that a new crop of Consumer Safety Officers (CSO’s) or analysts come on board, productivity actually drops as the experienced investigators are pulled out of line to train the newbies. I can’t see how ORA will overcome this challenge and double the number of foreign inspections in 2012, or increase them by 600 per year for the next several years.

CSO productivity has been a concern of ORA management for several years. Mr. Sklamberg explained that ORA will continue to expand the use of handheld computers to help its investigators. Field managers will welcome the use of these and other technical innovations to help increase productivity. I would suggest another labor-saving initiative; If ORA hasn’t already done so, it should eliminate the writing of extensive reports for non-actionable inspections.

Imports will continue to pose a significant challenge and it is unclear whether the agency will have the resources to adequately regulate them. Improved technology including the PREDICT system will help. But there is no substitute for sufficient numbers of experienced CSOs and inspectors at the ports.

New enforcement tools provided by the FSMA including mandatory recall, expanded records access, expanded administrative detention and suspension of registration, will be a huge benefit to the agency provided the agency finds efficient ways to use them. I believe the tools will be of most benefit if they are not made too difficult for regular use.

Mr. Sklamberg mentioned FDA’s enhanced ability to “fingerprint” bacteria involved in outbreaks. The new prevention measures introduced by the FSMA should help reduce the frequency and severity of outbreaks associated with foods, but it will not eliminate outbreaks. So FDA and associated federal, state and local health agencies need to be able to move quickly to identify the source of an outbreak and to alert the public. At the same time the agency comes under great pressure to be right every time in identifying the source. I believe there will always be a trade-off between speed and certainty.

Mr. Sklamberg ended his presentation with several hopeful conclusions. Besides the prospect of added safety and security for consumers, he suggested that industry may see fewer inspections in the future, with streamlined regulation, a level playing field between foreign and domestic producers, and the elimination of the competitive advantage of non-compliance. Certainly, these are good long-term goals, but we can’t expect to see them achieved in 2012.

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FSMA Perspective
New Training Alliance Targets Food Safety Preventive Controls

by EAS Consulting Group Editor Declan Conroy

The Food and Drug Administration missed an end-of-year target date for issuing proposed preventive control regulations for food and animal feed, but says it is on track to issue them in early 2012. The agency recognizes that effective training will be a key component of new preventive measures, and it has awarded a one-year $1 million grant to the Illinois Institute of Technology to develop training materials as part of the newly formed Food Safety Preventive Controls Alliance (FSPCA).

The alliance is a collaborative effort modeled on the Seafood HACCP Alliance created in 1994 and on the Produce Safety Alliance launched in 2010. The organizing committee for the new alliance held its first meeting December 20-21, 2011, in Washington, D.C.

IIT’s Institute for Food Safety and Health (IFSH) will play a lead role in the alliance and will develop training materials on the prevention of contamination to help the industry comply with new preventive control regulations issued as FDA implements the Food Safety Modernization Act.

The new alliance includes representatives of state and local agencies, the food industry and academia.

Under the FSMA, facilities are required to develop food safety plans that evaluate food safety hazards, and identify the preventive measures to guard against those hazards. The plans must also describe how manufacturers will monitor their preventive measures to ensure they are working, and keep records of that monitoring. Manufacturers also must develop a plan of action to correct problems.

The alliance will develop standardized hazard analysis and preventive controls training and distance education classes for food industry and regulatory personnel. This will include an online training portal at the IFSH Moffett Campus in Bedford Park, Ill. In addition, the FSPCA will develop “train-the-trainer” materials and student education modules, as well as a technical assistance network for small- and medium-sized food companies.

Other goals include the development of commodity-specific and sector-specific guidelines for preventive controls, the identification of knowledge gaps and research needs for improving control measures, and the compilation of critical limits for widely used preventive controls.

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Who's Who at EAS

Meet EAS Senior Consultant Joe Baca

Joseph R. Baca, former director of the Office of Compliance at the Center for Food Safety and Applied Nutrition, joined EAS as a senior consultant in 2010.

Mr. Baca served for almost a decade as the director of CFSAN’s Office of Compliance. In that role, he was responsible for managing import and domestic regulatory matters for foods and dietary supplements, working with other offices in the center to make decisions on recommendations from the FDA Field Offices and initiating and managing regulatory actions. He was also responsible for preparing the FDA Field work plan and objectives for each fiscal year and for issuing special assignments to the FDA Field Offices.

Mr. Baca began his FDA career as a chemist in the Minneapolis District Office in 1971 and went on to serve as a compliance officer in that office from 1977 to 1987. From 1987 to 1996 he was the Compliance Branch director in the Seattle District Office. Subsequently, he spent three years as director of the Dallas District Office.

“Joe’s extensive knowledge of FDA compliance matters is a significant benefit for our clients, and we are very fortunate to have him in our network of consultants,” says EAS President Ed Steele.

EAS Adds Three New Consultants

Robert Mehta, Frederick Lochner and Michael Pierce are the latest additions to the EAS network of senior consultants.

Mr. Mehta has more than 20 years of GMP experience with Fortune 500 pharmaceutical and medical device companies, principally with Allergan Inc., of Irvine, Calif., which he joined in 1989 as a senior lab technician and advanced to become senior manager of worldwide quality assurance. Subsequently, he joined Edwards Lifesciences as senior manager for regulatory compliance and associate director. Since February 2010, he has been principal consultant for GMP ISO Expert Services in Mission Viejo. Mr. Mehta is an experienced instructor for risk management, GMP/QSR, Lean, and Six-Sigma certification courses. He holds a B.Sc. in chemistry from Ahmedabad Science College in Ahmadabad, India, as well as an MBA from Pepperdine University in Malibu, Calif., and an M.Sc. in quality assurance from California State University.

Mr. Lochner spent more than three decades as an FDA investigator working in five district offices, including Newark, Buffalo (Albany, N.Y.), Seattle (Portland, Ore.), Detroit (Indianapolis, Indiana), and Cincinnati (Akron/Brunswick, Ohio), where he inspected drug manufacturing facilities, including small volume parenterals, aseptic filling and terminal sterilization, sterile ophthalmics, computer controlled bulk drug operations, tablets, capsules, liquids, antibiotics, time release formulations, clinical research feed mills, and medical gases. Since his retirement from the agency in 2005, he has performed domestic and international supplier and internal audits of drug and API manufacturers and testing laboratories for compliance with FDA regulations. He holds a B. Sc. degree in biology (cum laude) from the University of New York at Albany.

Mr. Pierce has more than 34 years of governmental and industry experience in regulatory and quality compliance. He spent five years as an FDA investigator and 29 years in the pharmaceutical industry in a variety of senior positions in regulatory affairs and quality compliance with Glaxo Smithkline, Inc. He has extensive international experience in quality audits, quality management systems and preparing for and participating in domestic and foreign GMP inspections. He holds a B.A. degree from the University of Louisville and an MBA in Management from East Tennessee State University. Mr. Pierce is Regulatory Affairs Certified by the Regulatory Affairs Professionals Society (RAPS).

Promotions for Gisela Leon and Madhu Soni

EAS is pleased to announce the promotion of Gisela Leon from Consultant to Senior Consultant and of Dr. Madhu Soni from Senior Consultant to Expert.

Ms. Leon is a former director of quality management for Schöller Lebensmittel in Germany. She joined EAS in 2006. As an EAS consultant, she helps clients assure compliance with U.S. labeling requirements for food and dietary supplements. She is also expert in European food law and multi-language labeling for various countries.

She speaks English, German, and French and can assist companies in ensuring that their products meet U.S., EU and other foreign labeling requirements. She has a Master’s degree in food technology engineering—the equivalent of food science in the U.S.—as well as a Master’s degree in business.

Dr. Madhu Soni is a biochemist with extensive experience in regulatory issues related to product safety and risk assessment. In addition, he has broad experience in the planning, conducting and reporting of clinical trials.

Dr. Soni received his doctorate in Biochemistry at Marathwada University in India, followed by post-doctoral training at Jichi Medical School in Japan and the University of Mississippi Medical Center in Jackson, Mississippi.

From there he joined the National Institute of Nutrition in Hyderabad, India, as a research scientist. He went on to become Research Assistant Professor at the University of Louisiana, Monroe. His research training included toxicokinetics, toxicodynamics, cancer biomarkers, chemoprevention, molecular toxicology, and clinical trials.

Dr. Soni has authored more than 50 peer reviewed articles in scientific journals. He received numerous awards for his research work, notably the Board of Publications Award for the Best Paper Published in Toxicology and Applied Pharmacology in 1999, and the Best Paper Award from the Risk Assessment Specialty Section of Society of Toxicology in 1998.

Prior to joining EAS as a consultant in 2006, Dr. Soni was director of research at Vero Beach Hematology Oncology and at a toxicology consulting firm.

Dr. Soni can offer assistance with safety determinations for food and cosmetic ingredients. In addition, he can help with strategies for usage and approval of ingredients, GRAS determinations, and the design and management of clinical trials.

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What's New on FDA's Website

Listed below are links to new additions to the FDA website for the month of December, 2011. Use of this section of EAS-e-News is intended to provide an "easy" way to keep current with FDA news and information.

• FDA expands use of Prevnar 13 vaccine for people ages 50 and older December 30, 2011


• FDA to approve shared system REMS for TIRF products December 29, 2011


• FDA: Chicago-area sandwich manufacturer agrees to stop production December 22, 2011


• FDA expands use of HIV drug Isentress to children and adolescents December 21, 2011


• FDA: Do not use ShoulderFlex Massager December 21, 2011


• FDA collaboration to monitor rare eye condition associated with cataract surgery December 20, 2011


• FDA approves mechanical cardiac assist device for children with heart failure December 16, 2011


• FDA proposes draft guidelines intended to improve the representation of women in medical device clinical studies December 16, 2011


• FDA Statement on the Institute of Medicine Report: Scientific Standards for Studies on Modified Risk Tobacco Products December 14, 2011


• FDA permits marketing of the first hand-held device to aid in the detection of bleeding in the skull December 13, 2011


• FDA issues Warning Letters for misleading advertising of Lap-Band December 13, 2011


• FDA: U.S. Marshals seize products containing banned ephedrine for dietary supplements December 6, 2011


• FDA announces changes to risk strategy requirements for 2 drugs to treat low platelet counts December 6, 2011


• FDA, FTC act to remove “homeopathic” HCG weight loss products from the market December 6, 2011


• FDA: U.S. Marshals seize dietary supplements, drugs manufactured by Syntec Inc. December 1, 2011


• FDA outlines flexible approaches for artificial pancreas system clinical trials, product approvals December 1, 2011

• Consumer Alert for Cheese and Milk Products Due to Listeria monocytongenes Contamination December 30, 2011


• Undeclared Sulfites in Baraka Apricot Candies, from Lebanon December 29, 2011


• Winn-Dixie Issues Voluntary Recall on Winn-Dixie Brand Italian Green Beans December 29, 2011


• O'Neal's Feeders Supply, Inc. Recalls Arrow Brand Dry Dog Food December 28, 2011


• Green Cedar Dairy Announces the Recall of All Natural Ackawi Cheese and All Natural Chives Cheese with a sell by date up to July 1, 2012 due to Possible Listeria Contamination December 28, 2011


• Petrus Feed and Seed Stores, Inc. recalls its 21% Dog Food December 28, 2011


• Updated New Release With Corrected Lot Numbers Petrus Feed and Seed Stores, Inc. recalls its 21% Dog Food December 28, 2011


• Smiths Medical Issues Urgent Ddevice Recall of Certain Bivona Neonatal, Pediatric, and Fflextend Tracheostomy Tubes December 27, 2011


• Kradjian Imp Co. Recalls Cedar Brand Tresse Cheese and Cedar Brand Shinglish Cheese Because of Possible Health Risk December 26, 2011


• RECALL Green Valley Food Corp. is Expanding Its Recall to Include The Following Items Because of a Possible Health Risk. December 24, 2011


• Eillien's Candies, Inc. Issues a Voluntary Recall of Select Candy Items Due to Possible Health Risk. December 23, 2011


• Avon Heights Mushrooms, Inc. Recalls Fresh Spinach Because of Possible Health Risk December 23, 2011


• Maribel Sweet’s Inc. Recalls Their New York Handbag Collection Gourmet Chocolate Candies Due To Undeclared Tree Nuts And Peanuts December 23, 2011


• Price Chopper Supermarkets Issues Voluntary Cheesecake Recall December 23, 2011


• Sirocco Enterprises, Inc. Issues Allergy Alert On Undeclared Soy And Wheat In Pat O'Brien's Bloody Mary Cocktail Mix December 23, 2011


• IKARIA® Issues Notice of Completed Remediation For INOMAX® DS Drug-Delivery System December 23, 2011


• RECALL Green Valley Food Corp. "Let's Grow Healthy Together!" Alfalfa Sprouts 5 oz. containers because of a possible health risk. December 23, 2011


• McNeil Recall of Motrin IB Tablets and Caplets December 22, 2011


• CareFusion Provides Update on Previously Announced Ventilator Recall December 22, 2011


• Market Basket Initiates Limited Regional Voluntary Recall of Market Basket Solid White Albacore Tuna in Water 5 oz. Product Due to Undeclared Allergen December 22, 2011


• Starwest Botanicals Recalls Starwest Organic Celery Seed. Due to Potential Salmonella Contamination. December 21, 2011


• Cal Fresco, LLC Recalls Jalapeño and Serrano Chili Peppers Due to Possible Health Risk December 21, 2011


• Eclectic Institute Voluntarily Recalls Specific Dietary Supplements Containing Gotu Kola (Centella Asiatic) And Bladerwrack (Fucus Vesiculosus) Because Of Possible Salmonella Contamination December 21, 2011


• Popcorn Palace Issues Allergy Alert on 1-Gallon Value Bag Products December 20, 2011


• Consumer Alert: Undeclared Milk In Gollo Brand "Pan Dominicano (Dominican Bread)" December 20, 2011


• Ohio Processors, Inc. Issues Allergy Alert on Undeclared Milk Allergens in “Instantwhip B/C Topping” (Whipped Topping) December 18, 2011


• B&M, Inc. Conducts A Voluntary Recall Of O Organics Organic Celery Seed Sold At Safeway Nationwide Due To Possible Salmonella Contamination December 17, 2011


• Swanson Health Products Recalls Swanson Organic Celery Seed December 16, 2011


• FDA Classifies Voluntary Physician Advisory Letter on Riata and Riata ST Silicone Defibrillation Leads as Class I Recall (URGENT MEDICAL DEVICE ADVISORY) December 15, 2011


• Velvet Creme Popcorn Co. Issues Allergy Alert On Undeclared Milk, Soy, And Wheat In Products December 15, 2011


• Rising Moon Organics Announces a Voluntary Recall of One Code Date of Mislabeled Mediterranean Garlic & Herb Ravioli Due to Undeclared Soy Allergen December 14, 2011


• Winn-Dixie Issues Voluntary Recall on Bulk Gummy Bears December 14, 2011


• Rhee Bros., Inc. Issues Allergy Alert on Undeclared Egg in "Assi" Brand Korean Cake (Gyeong Dan) December 14, 2011


• Advanced Animal Nutrition Recalls Dog Power Dry Dog Food December 12, 2011


• Pacific International Marketing Voluntary Recalls Product Because of Possible Health Risk December 10, 2011


• Voluntarily Recall of Limited Quantity of 12 oz Tejava® Premium Iced Tea December 9, 2011


• See’s Candies, Inc. Issues Allergy Alert on 8 ounce Almond Clusters, Code SF 088/12 December 7, 2011


• Product Recall: Fair Oaks Dairy Products Issues Voluntary Recall For Fair Oaks Farms Fine Cheeses Half Pound Packages Because Of Possible Health Risk Due to Listeria Monoctyogenes Contamination December 7, 2011


• Cargill Animal Nutrition Recalls River Run and Marksman Dry Dog Food December 7, 2011


• **UPDATE** -- Ocean Spray Voluntarily Recalls Limited Quantity of Original Flavor Craisins Dried Cranberries in Western U.S. Only December 7, 2011


• Mars Food US Recalls Two Date Codes of UNCLE BEN'S Whole Grain White Rice Garden Vegetable Due to Undeclared Milk December 6, 2011


• P&G Voluntarily Recalls One Production Lot of Dry Dog Food December 6, 2011


• Flying Food Group Updates Recall of Sandwiches Because of Possible Health Risk December 5, 2011


• Golden Glen Creamery Issues Voluntary Recall Of Butter Because Of Possible Health Risk December 3, 2011


• Krasdale Foods Inc. Issues Allergy Alert On Undeclared Almonds In Krasdale Crispy Honey Oats and Flakes December 2, 2011


• Flowers Foods Pulls Nature's Own Butterbread Off Store Shelves in Certain Floriday and Southeast Georgia Counties December 2, 2011


• Front Row Produce Recalls Grape Tomatoes Because Of Possible Health Risk December 1, 2011

• December 15, 2011 Prescription Drug Shortages: Examining a Public Health Concern and Potential Solutions
  Sandra Kweder, M.D., before the Senate Committee on Health, Education, Labor and Pensions

• December 28, 2011
• December 21, 2011
• December 14, 2011
• December 7, 2011

• Food
• Drugs
• Medical Devices
• Tobacco Products
• Biologics
• Animal Feed and Drugs
• Radiation Protection
• Cosmetic
• Toxicological Research
• Regulatory Affairs

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EAS in Action

EAS Supports FDLI’s Food Week

EAS is pleased to be sponsoring the Food and Drug Law Institute’s annual Food Week in Washington, D.C., January 23-26, 2012. This event offers food law and regulation professionals an excellent opportunity for networking and for catching up on the latest legal and regulatory developments affecting all sectors of the food industry.

To receive a 15% discount off registration use the following promotional code: FOODPRTNR.

Food Week is a unique opportunity for food law and regulation professionals. The conference will provide practical guidance and an educational forum on the latest legal and regulatory developments affecting all sectors of the food industry and go to the core of what food safety experts, food engineers, food law practitioners and food manufacturers do every day. Food Week 2012 consists of three days of advanced programming in advertising and labeling, food safety and global issues, as well as FDLI's industry standard "Introduction to Food Law and Regulation" course.

EAS Vice President Elizabeth (Betty) Campbell, a former acting director of FDA’s Office of Food Labeling, will take part in an expert panel on nutritional labeling at a session on Advertising, Labeling and Nutrition: Legal Developments on January 24.

EAS Contributes to FDLI Book on the Food Safety Modernization Act

EAS has contributed a chapter on hazard analysis and preventive controls for a new FDLI book, titled The Food Safety Modernization Act: A Comprehensive Guide to the Landmark Legislation. The book provides in-depth analysis of the FSMA’s history and its major provisions.

EAS President Ed Steele, EAS Senior Consultant John Kvenberg, and EAS Consulting Editor Declan Conroy co-authored Chapter Two on hazard analysis and preventive controls. Dr. Kvenberg, a former FDA strategic manager for HACCP policy and member of the National Advisory Committee on Microbiological Criteria for Foods, brought a most valuable perspective to the analysis.

In addition, EAS Senior Consultant Mike Olson contributed to a separate chapter titled “Noteworthy Miscellaneous Provisions,” in which he reviews FSMA’s provisions on laboratory accreditation and the Integrated Consortium of Laboratory Networks.

Joe Baca Writes Article Titled, “What Importers Can Expect from FSMA,” for Organic Processing Magazine

The Food Safety Modernization Act will change the way imported and domestically produced food is regulated says EAS Senior Consultant, Joe Baca, in an article titled “What Importers Can Expect from FSMA,” in the upcoming issue of Organic Processing Magazine. FSMA places the responsibility for assuring that imported foods are safe squarely on the shoulders of food importers and imposes additional requirements for conventional and organic foods and food ingredients, he says. The Act also requires all food importers, manufacturers and producers to build food safety into the foods FDA regulates rather than having the industry and FDA react to outbreaks through press releases and recalls.

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Upcoming Events

EAS Announces Next Food Labeling Seminar

You can to sharpen your understanding of food labeling compliance requirements at the next Food Labeling Compliance Review Seminar, which will be held at the EAS training facility in Alexandria, Va., May 22-23, 2012.

This in-depth training event is designed for individuals involved in management, regulatory affairs, and quality control/assurance in the manufacturing of foods, as well as those responsible for preparing or reviewing food labels. It is also helpful for consultants, auditors, attorneys and others interested in food labeling compliance.

Instructors for this event will include EAS Vice President Elizabeth (Betty) Campbell, former acting head of the FDA Office of Food Labeling in the Center for Food Safety and Applied Nutrition, and EAS Senior Consultants James Hoadley, and Gisela Leon.

Mark your calendars. The details will be posted on the EAS web site soon.

EAS Prepares for Jan. 17-18 Dietary Supplement GMP Seminar

There is still time to sign up for the next EAS Dietary Supplement GMP Seminar, which will be held at the EAS Training Facility, in Alexandria, VA., January 17-18, 2012. The seminar addresses the responsibilities of domestic and foreign firms who manufacture, label, pack or hold dietary supplements for sale in the United States, including those involved with the testing, quality control and distribution of supplements.

EAS Vice President Dean Cirotta and EAS Senior Consultant William Ment will be the instructors for this popular seminar.

Visit the EAS web site for more details.

Upcoming Events

Dietary Supplement GMP Seminar
January 17-18, 2012
Alexandria, VA
(EAS Training)

FDLI – Food Week
January 23-26, 2012
Washington, DC
(EAS Sponsoring/Exhibiting/Presenting)

Food Labeling Compliance Review Seminar
May 22-23, 2012
Alexandria, VA
(EAS Training)

FDLI – Annual Conference
April 24-25, 2012
Washington, DC
(EAS Sponsoring/Exhibiting/Presenting)

Supply Side Marketplace
May 8-10, 2012
New York, NY
(EAS Exhibiting)

Tobacco Merchants Association Conference
May 20-22, 2012
Williamsburg, VA
(EAS Exhibiting/Presenting)

IFT - Annual Meeting and Food Expo
June 25-28, 2012
Las Vegas, NV
(EAS Exhibiting)

Drug Information Association (DIA)
June 24-28, 2012
Philadelphia, PA
(EAS Exhibiting)

Parenteral Drug Association (PDA) FDA Joint Regulatory Conference
September 10-12, 2012
Baltimore, MD
(EAS Exhibiting)

SupplySide West
October 10-13, 2012
Las Vegas, NV
(EAS Exhibiting)

Regulatory Affairs Professional Society – Annual Conference
October 26-30, 2012
Seattle, WA
(EAS Exhibiting)

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Order Publications and Regulatory Tools

	EAS Labeling Type Size Guide A handy tool for measuring type size, package dimensions and line width on food, dietary supplement, cosmetic and OTC drug labels.	$ 9.00
	Dietary Supplement GMP Regulation - A Pocket Guide A 4"x6" bound copy of 21 CFR Part 111 designed to fit in shirt pockets of management and plant personnel.	< 25 $ 10.00 each 25-50 $ 9.00 each 50-100 $ 8.00 each > 100 $ 7.00 each
	Pharmaceutical GMP Regulation - A Pocket Guide A 4"x6" bound copy of 21 CFR Part 210, 211 and 11 designed to fit in shirt pockets of management and plant personnel.	< 25 $ 10.00 each 25-50 $ 9.00 each 50-100 $ 8.00 each > 100 $ 7.00 each
	No Margin for Error – GMP Training Video A 1967 video produced by FDA demonstrating the consequences of not following GMPs. An excellent training tool to motivate employees to follow drug GMPs. 25 minute video in DVD format	$ 99.00
	Dietary Supplement Labeling Compliance Review, 3rd edition A valuable labeling reference authored by EAS Senior Consultant, James Summers, with contributions from EAS VP, Elizabeth Campbell Book	$ 200.00
	Food Labeling Compliance Review, 4th edition A valuable labeling reference authored by EAS Senior Consultant, James Summers, with contributions from EAS VP, Elizabeth Campbell. Hardbound book and CD	$ 240.00 / set
To purchase any items listed above download our

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