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EAS Consulting Group, LLC · 1940 Duke Street, Suite 200; Alexandria, VA 22314 · (703) 684-4408
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February 2009 |
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In this Issue:
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Upcoming EAS Events |
- Free EAS GMP Challenge [more]
- Food Labeling Compliance Review Seminar and Update [more]
- Dietary Supplement GMP Seminar [more]
- Ensuring Regulatory Compliance of Dietary Supplement Laboratories Seminar [more]
- OTC Drug and Cosmetics Labeling Compliance Reveiw Seminar [more]
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From the Desk of the President:
A Time to Embrace Change
Dear Reader:
Welcome to the February issue of EAS-e-News, our free, monthly newsletter for industries regulated by the Food and Drug Administration.
With only days to go until the free EAS GMP Challenge webinar (February 5 at 2 p.m. EST), I encourage you to sign up now and take this opportunity to grill FDA’s regulators and our own experts on the agency’s final rule on current Good Manufacturing Practice requirements for dietary supplements (See details below).
In our related “Issue of the Month” article, we focus on the things dietary supplement laboratories often get wrong in their cGMP compliance efforts. EAS Senior Consultant William Ment, a leading expert in laboratory operation, describes some of the shortcomings he has seen while conducting gap assessments.
Despite the economic uncertainty, EAS continues to be in a phase of steady expansion and I am delighted to welcome another senior consultant, Denis M. Kluba, to our expert team. Mr. Kluba is a former vice president of validation at AAC Consulting Group.
FDA’s drugs centers took a hit last month when the U.S. Government Accountability Office added FDA oversight of medical products to its list of federal programs, policies, and operations that are at “high risk” for waste, fraud, abuse, and mismanagement or in need of broad-based transformation. The GAO list, which is updated every two years, is used by each new Congress to focus their oversight.
The agency’s food officials, meanwhile, scrambled to keep up with a tide of recalls arising from the nationwide outbreak of salmonellosis linked to contaminated peanut products.
Newly named Acting FDA Commissioner, Dr. Frank M. Torti, in his first public message, urged the agency to embrace change. His January 21 remarks are available as an audio file on FDA's web site. Before joining FDA as chief scientist last April, Dr. Torti was a professor at the Wake Forest University School of Medicine, where he chaired the Department of Cancer Biology.
I agree with Dr. Torti’s sentiment that FDA (and every organization) needs to embrace change at this time. They key is to change in a way that will ensure public confidence in regulatory oversight while allowing the regulated companies to thrive.
Sincerely,
Ed Steele,
President
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Who's Who at EAS:
Meet EAS Senior Consultant William Ment
William Ment--an acknowledged expert in laboratory quality assurance issues --is a key member of the EAS consulting team.
A former FDA laboratory director in Baltimore, Md., he left the agency in 1999 after a 34-year career. As lab director, he was responsible for field lab sample analyses and research studies for imported and domestic products. From 1970, his responsibilities included laboratory quality assurance systems and procedures, as well as the training and evaluating of lab personnel in their use.
Mr. Ment’s wide experience extends to dietary supplements, including the training of industry personnel in implementing FDA’s final rule on current Good Manufacturing Practices. He is a regular instructor in EAS seminars, where he shares his unique insights on the agency and its approach to regulation and compliance.
Since leaving the agency almost a decade ago, Mr. Ment has performed audits of Active Pharmaceutical Ingredient, dosage form, and excipient manufacturers and contractors, and has helped companies to improve their laboratory and QC/QA operations. He has also critiqued New Drug Application and Drug Master File submissions and performed good laboratory practice audits for non-clinical laboratory studies.
As an EAS senior consultant, Mr. Ment is available to assist with laboratory cGMP issues, 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, deviation and batch failure investigations; and issues resulting from FDA inspections. He is also able to assist with the Chemistry, Manufacturing and Controls sections of drug applications.
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Issue of the Month
Where Dietary Supplement Labs Go Wrong
By William Ment, Senior Consultant
How well do you know your suppliers? Do you test ingredients to ensure they are what suppliers claim them to be? Do you verify your suppliers’ certificates of analysis? Perhaps you do not view these steps as relevant to your compliance with 21 CFR Part 111 current Good Manufacturing Practice requirements for dietary supplements. If so, you may be making a big mistake.
EAS consultants have performed numerous audits of dietary supplement companies, in the United States and elsewhere, for compliance with FDA’s cGMP regulations. Almost every facility we visited required a considerable amount of work to become GMP-compliant. This was usually not for lack of a conscientious effort. However, every lab had significant compliance issues.
Analytical testing plays a key role in ensuring that raw materials, in-process materials, and finished products meet the specifications established by the firm. Our audits have revealed that, in practice, there are almost always regulatory gaps. For example, some companies fail to conduct definitive identification testing of the active dietary ingredients they get from their suppliers. Or they may fail to initially adequately verify the accuracy of the suppliers’ other test results for the raw material before relying on the supplier’s Certificate of Analysis without further testing of their own to ensure the quality of the material.
Another gap we often find in our audits is a failure to ensure that the lab staff has the necessary skills and cGMP training before they are allowed to conduct particular lab activities. Other frequent gaps we have seen include:
- A lack of proper procedures to ensure that reference standards, reagents, and analytical solutions are properly labeled, stored, used within established expiry periods, and tested prior to use as necessary.
- Inadequate qualification, calibration and preventive maintenance for instruments and equipment.
- Inadequate raw material sampling plans and failure to follow the established sampling scheme.
- Failure to identify and justify adequate product testing schemes to ensure the quality of the finished product.
- Failure to perform and/or document validation or verification of computer programs used in the lab and in other parts of the facility.
- Inadequate testing to ensure analytical methods are scientifically valid.
- Inadequate programs to demonstrate that the dietary ingredients in the finished product are stable at least until its expiration date, by testing the product at appropriate intervals under controlled temperature and humidity conditions.
- Lack of or inadequate SOPs for laboratory processes and procedures.
- Inadequate QC review and approval of laboratory processes and procedures. Quality assurance staff has to exert oversight of numerous GMP activities in the facility and they have to document that they have done so.
- Failure to ensure that any testing performed by contract laboratories is reliable and is in compliance with GMP requirements.
- Inadequate change control processes for GMP-related activities, including documentation of change requests, justifications, and approvals by QA/QC.
These shortcomings can be overcome by effective quality assurance operations and controls. Complete and accurate documentation of analytical testing, training and other lab activities will also go a long way toward keeping a dietary supplement laboratory on the right side of the regulators.
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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 January, 2009. Use of this section of EAS-e-News is intended to provide an “easy” way to keep current with FDA news and information.
FDA Press Releases
- FDA Warns Consumers Against Dietary Supplement Containing Undeclared Drug January 27, 2009
- FDA Updates Information on Salmonella Typhimurium Investigation January 19, 2009
- FDA Approves RiaSTAP for Treatment of Bleeding in Patients with Rare Genetic Defect January 16, 2009
- FDA Alerts Public about Danger of Skin Numbing Products January 16, 2009
- FDA Consumer Health Information Update For This Week January 15, 2009
- FDA Issues Guidances for Industry to Improve the Safety of Food, Feed and Drugs January 15, 2009
- FDA Issues Final Guidance on Regulating Genetically Engineered Animals January 15, 2009
- FDA Launches Pilot Program To Improve the Safety of Drugs and Active Drug Ingredients Produced Outside the United States January 14, 2009
- FDA Announces Two Appointments January 12, 2009
- Federal Agencies Issue Draft Guidance for Industry Good Importer Practices January 12, 2009
- FDA Awaits Court's Entry of A Permanent Injunction Against Actavis Totowa, LLC January 9, 2009
- FDA Issues Update to Safety Review on Cholesterol-Lowering Drugs January 9, 2009
- FDA Prevents Two Dairies from Adulterating Animal Drugs and Food January 2, 2009
- FDA Announces Class I Recall of Ophthalmic Surgical Device January 2, 2009
Recalls and Safety Alerts
- Meijer Announces Voluntary Recall for Some Meijer Brand Peanuts and Ice Cream Novelties Citing Possible Health Risk
January 30, 2009
- Rain Creek Baking Corporation Announces An Expanded Voluntary Withdrawal of Peanut Butter Turtles, Peanut Butter Baskets and Peanut Butter Princesses Due to Possible Health Risk January 30, 2009
- Galliker Dairy Announces Voluntary Recall of Rocky Road Ice Cream and Sundae Nut Cones Because of Possible Health Risk January 30, 2009
- Simbree Energy Foods RECALLS Simbree® Oat Almond Pistash, Simbree® Almond Pistachio Energy Bites and Simbree® Oat Bites with Peanuts, Almonds and Pistachios/ Bouchées d’avoine aux arachides, amandes et pistaches Because of Possible Health Risk January 30, 2009
- Voluntary Recall Alert: Chef Pierre Chocolate Peanut Butter Silk Pie January 30, 2009
- Turkey Hill Dairy Announces Voluntary Recall of Select Ice Cream Flavors Following Expanded FDA Investigation of Peanut Corporation of America January 30, 2009
- NutriSystem Expands Voluntary United States Recall of Peanut Butter Granola Breakfast Bar to Include Canada Due to Possible Peanut Corporation Of America (PCA) Contamination and Potential Health Risk January 30, 2009
- House of Flavors Issues Voluntary Recall in Eastern United States Due to Possible Health Risk January 30, 2009
- Wells' Dairy Announces Voluntary Recall of Select Blue Bunny Products Because of Possible Health Risk January 29, 2009
- Wegmans Food Markets, Inc. Recalls Three Bakery Products with Peanuts January 29, 2009
- Fieldbrook Foods Corp. Announces Nationwide Voluntary Recall of Select Ice Cream Novelty Products Due to Possible Health Risk January 29, 2009
- Hy-Vee Inc. Recalls Two Bakery Products with Peanuts Distributed in Seven States Due to Possible Health Risk January 29, 2009
- Country Maid Expands Upon Previous Voluntary Nationwide Recall of Classic Breaks Peanut Butter Cookie Dough Due to Possible Health Risk January 29, 2009
- Orchard Valley Harvest Announces Urgent Nationwide Voluntary Recall for Peanuts Because of Possible Health Risk January 29, 2009
- Arico Natural Foods Company Announces US and Canadian Recall of Arico Peanut Butter Cookies and Cookie Bars Because of Possible Health Risk January 29, 2009
- Ther-Rx Corporation Issues Nationwide Voluntary Recall of Products January 28, 2009
- ETHEX Corporation Issues Nationwide Voluntary Recall of Products January 28, 2009
- House of Flavors Issues Allergy Alert for Undeclared Walnuts in Hanniford Chocolate Chip Ice Cream Sold at Sweetbay Supermarkets in Florida January 28, 2009
- Peanut Corporation of America Expands Nationwide Recall of Peanut Products January 28, 2009
- Uncle Eddies Vegan Cookies Announces Recall of Uncle Eddies Vegan Peanut Butter Chocolate-Chip Cookies Because of Possible Health Risk January 28, 2009
- FDA Warns Consumers Against Dietary Supplement Containing Undeclared Drug January 27, 2009
- SOPAKCO, Inc. Announces a Nationwide Recall of Certain SURE-PAK 12 Meals Containing Peanut Butter Products January 27, 2009
- Carolina Prime Pet Announces Nationwide Recall of Dog Treats January 27, 2009
- Jenny Craig Announces Nationwide Voluntary Recall of Jenny’s Cuisine® Anytime Peanut Butter Flavor Nutritional Bars Due to Possible Peanut Corporation of America (PCA) Contamination and Potential Health Risk January 27, 2009
- Isagenix Announces Voluntary Recall of Chocolate Dipped Honey Peanut IsaLean® Bar Due to Possible Peanut Corporation of America (PCA) Contamination and Potential Health Risk January 27, 2009
- Voluntary Recall Issued for ShopRite Peanut Butter on Toasty Crackers and ShopRite Peanut Butter and Cheese Cracker Snacks Because of Possible Health Risk January 24, 2009
- Salix Voluntarily Recalls Dog Treat Due to Possible Health Risk January 23, 2009
- Brent and Sam’s Announces Nationwide Recall of Two Varieties of Archer Farms Brand Cookies January 23, 2009
- Brent and Sam’s Announces a Nationwide Recall of One Variety of Sam’s Choice Brand Cookies January 23, 2009
- Amway Global Initiates Nationwide Recall of NUTRILITE Energy Bars Because of Possible Health Risk January 23, 2009
- Whole Foods Market Recalls "Whole Foods Carob Energee Nuggets” January 23, 2009
- Stonewall Kitchen Voluntarily Recalls Seven Dessert Sauces January 23, 2009
- Supreme Protein Voluntarily Recalls Supreme Protein® brand Peanut Butter Crunch Bars and Caramel Nut Bars January 23, 2009
- Trader Joe’s Expands Its Voluntary Recall To Include Trader Joe’s Sliced Green Apples With All Natural Peanut Butter January 23, 2009
- Falcon Trading Company/SunRidge Farms Withdraws Naturally Preferred Honey Nut Nuggets January 23, 2009
- Falcon Trading Company/SunRidge Farms Withdraws Certain Lots of SunRidge Tropical Golden Nugget, SunRidge Chocolate Energy Bar and SunRidge Energy Nuggets January 23, 2009
- ALDI Statement Regarding Peanut Butter Products Recall January 23, 2009
- Aspen Hills, Inc. Announces Voluntary Product Recall of Certain Cookie Dough Products January 22, 2009
- Nash Finch Recalls Bakery Products With Peanut Butter Distributed in Seven States Due to Possible Health Risk January 22, 2009
- South Bend Chocolate Company Extends Nationwide Recall of Candy Containing Peanut Butter Because of Possible Salmonella Contamination January 22, 2009
- Rain Creek Baking Corporation Announces Voluntary Withdrawal of Peanut Butter Turtles, Peanut Butter Baskets and Peanut Butter Princesses Due to Possible Health Risk January 22, 2009
- Chef Jay’s Food Products Announces Voluntary Nationwide Recall of Products Containing Peanut Butter Due to Possible Health Risk January 22, 2009
- General Nutrition Centers, Inc. Announces Nationwide Voluntary Recall of Certain Lots of GNC Triflex Peanut Butter Soft Chews January 22, 2009
- Perry's Ice Cream Company Adds Two Products to Voluntary Recall of Select Peanut Butter Ice Cream Products January 22, 2009
- Jimmy's Cookies Issues Nationwide Recall of Various Peanut Butter Cookies Due to Possible Health Risk January 22, 2009
- Arbonne International Voluntarily Recalls Figure 8 Peanut Butter Chews Due To Possible Health Risk January 22, 2009
- Parker Products, Inc. Announces Nationwide Voluntary Recall of Certain Peanut Butter Products January 22, 2009
- Trader Joe’s Announces Voluntary Recall of Trader Joe’s Peanut Butter Chewy Coated & Drizzled Granola Bars, Nutty Chocolate Chewy Coated & Drizzled Granola Bars and Sutter’s Formula Cookies Due to Possible Health Risk January 22, 2009
- NutriSystem Announces Nationwide Voluntary Recall of Peanut Butter Granola Bar Due to Possible Peanut Corporation of America (PCA) Contamination and Potential Health Risk January 21, 2009
- Blanton's Candies Recalls Peanut Butter Sticks Because of Possible Health Risk January 21, 2009
- Landies Candies Co. Inc Announces Voluntary Recall of Select Peanut Butter Filled Chocolates Due to Possible Health Risk January 21, 2009
- Lovin Oven, LLC Announces Voluntary Nationwide Recall of Certain Health Valley Organic Peanut Crunch Chewy Granola Bars January 21, 2009
- Best Brands Corp. Announces Voluntary Recall of Peanut Butter Frozen Cookie Dough January 21, 2009
- Creative Energy Foods, Inc. Recalls Nutrition Bars Due To Possible Health Risk January 21, 2009
- Country Maid Announces Voluntary Nationwide Recall of Classic Breaks® Peanut Butter Cookie Dough Due to Possible Health Risk January 20, 2009
- Nature's Path Recalls Peanut Butter Optimum Energy Bars Nationwide Because of Possible Health Risk January 20, 2009
- PetSmart Voluntarily Recalls Grreat Choice® Dog Biscuits January 20, 2009
- Ready Pac Foods, Inc Announces Voluntary Product Recall January 20, 2009
- Premier Nutrition Announces Voluntary Nationwide Recall of selected TWISTED and TITAN Branded Bars Containing Peanut Butter Due to Possible Health Risk January 20, 2009
- Boca Grande Foods Announces a Nationwide Recall of POCO PAC®, and GRANDE GOURMET™ Peanut Butter Products Because of Possible Health Risk January 20, 2009
- Dinners Ready Meridian Recalls November & December Asian Marinated Flank Steak, Indonesian Chicken and Chicken Satay Prepared Meals Because of Possible Health Risk January 20, 2009
- Weis Markets Announces Voluntary Recall of Weis Quality (WQ) Cheese Peanut Butter Sandwich Crackers and WQ Toasted Peanut Butter Sandwich Crackers Due to Possible Health Risk January 20, 2009
- Kroger Recalls Additional Select Ice Cream Product Due to Possible Health Risk January 20, 2009
- Meijer Announces Voluntary Recall for Some Meijer Brand Peanut Butter Crackers and Ice Cream Because of Possible Health Risk January 19, 2009
- Abbott Nutrition Announces Voluntary Recall of ZonePerfect® Chocolate Peanut Butter Bars, ZonePerfect® Peanut Toffee Bars and NutriPals™ Peanut Butter Chocolate Bars in U.S., Mexico, New Zealand and Singapore January 19, 2009
- Kroger Recalls Select Ice Cream Products Due to Possible Health Risk January 19, 2009
- Clif Bar & Company Announces Voluntary Nationwide Recall of CLIF® and LUNA® Branded Bars Containing Peanut Butter Due to Possible Health Risk January 19, 2009
- Evening Rise Bread Co. Recalls Peanut Butter Cookies and Bars Because of Possible Health Risk January 19, 2009
- General Mills Issues Voluntary Recall of LÄRABAR and JamFrakas Peanut Butter Snack Bars January 19, 2009
- McKee Foods Corporation Announces Voluntary Nationwide Recall of Little Debbie® Peanut Butter Toasty and Peanut Butter Cheese Sandwich Crackers Because of Possible Health Risk January 18, 2009
- South Bend Chocolate Company Recalls Various Candys Containing Peanut Butter Because of Possible Salmonella Contamination January 18, 2009
- Ralcorp Frozen Bakery Products Recalls Wal-Mart Bakery Brand Peanut Butter Cookies Because Of Possible Health Risk January 18, 2009
- Ralcorp Frozen Bakery Products Recalls Lofthouse Peanut Butter Cookies, Chuck's Chunky Peanut Butter Cookies And Pastries Plus Gourmet Cookies Nationwide Because Of Possible Health Risk January 18, 2009
- Ralcorp Frozen Bakery Products Recalls Food Lion Bake Shop Peanut Butter Cookies Nationwide Because Of Possible Health Risk January 18, 2009
- Peanut Corporation of America Expands Nationwide Recall of Peanut Butter January 18, 2009
- Hy-Vee Inc. Recalls Bakery Products With Peanut Butter Distributed in Seven States Due to Possible Health Risk January 17, 2009
- Perry's Ice Cream Company Announces Voluntary Recall of Select Peanut Butter Ice Cream Products Due to Possible Health Risk January 17, 2009
- H-E-B Recalls H-E-Buddy Snack Packs With a Peanut Butter Dip January 17, 2009
- FDA Alerts Public about Danger of Skin Numbing Products January 16, 2009
- Salmonella-Tainted Peanut Butter Found in Connecticut January 16, 2009
- Kellogg Company Announces Voluntary Nationwide Recall of Austin® and Keebler® Branded Peanut Butter Sandwich Crackers and Select Snack-Size Packs of Famous Amos® and Keebler® Soft Batch Peanut Butter Cookies Because of Possible Health Risk January 16, 2009
- Peanut Corporation of America Expands Nationwide Recall of Peanut Butter January 16, 2009
- K-Fat Inc. Issues Alert on Uneviscerated Mackerel Fish January 16, 2009
- Kellogg Company Announces Precautionary Hold on Austin and Keebler Branded Peanut Butter Sandwich Crackers January 14, 2009
- Peanut Corporation of America Announces Voluntary Nationwide Recall of Peanut Butter January 13, 2009
- Salmonella recovered from King Nut peanut butter by MDA lab found to be a genetic match to cases in national Salmonella outbreak January 12, 2009
- King Nut Issues Peanut Butter Recall January 10, 2009
- Café Favorites Issues a Recall of Sandwiches Because of Possible Health Risks January 10, 2009
- FDA Awaits Court's Entry of A Permanent Injunction Against Actavis Totowa, LLC January 9, 2009
- Triple B Corporation dba S.T. Produce Issues Allergy Alert on Undeclared Allergens Walnuts and Almonds in Parfait Products January 9, 2009
- Celeste Industries Corporation Recalls All Lots of simplySmart Remove Make Up Remover January 5, 2009
- FDA Announces Class I Recall of Ophthalmic Surgical Device January 2, 2009
Enforcement Reports
What's New by Topic
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EAS in Action:
Validation Expert Joins EAS Team
EAS is pleased to announce the addition of Denis M. Kluba to its team of expert consultants. Mr. Kluba is an expert in validation and his specialty is the cost-effective integration of compliance requirements by pharmaceutical and medical device manufacturing organizations.
Mr. Kluba is a former vice president of validation for AAC Consulting Group, which became part of Kendle Regulatory Affairs in 2001. EAS Consulting Group, formerly a division of AAC/Kendle, became an independent company in October 2006.
Mr. Kluba has extensive consulting experience specializing in the assimilation of required regulatory practices into manufacturing operations. He has worked for large and small international engineering firms on compliance issues and for regulatory consulting groups as a consultant and manager of technical projects.
His career also included working with project and operation management in manufacturing companies, consulting and functional development of compliance issues, working within manufacturing operations on various functions and managing consulting specialist. His expertise includes current Good Manufacturing Practice requirements, FDA inspection expectations and the functions needed to efficiently meet regulatory compliance requirements.
Mr. Kluba has been involved in developing facilities, equipment and utilities qualification for numerous manufacturing operations including medical devices, Active Pharmaceutical Ingredients, finished pharmaceuticals and biotech production. His expertise includes review and development of design and drawing reviews, development of environmental monitoring program methods and procedures, cleaning validation, clean utilities support qualification protocols, packaging protocols, computer and automation systems qualifications and process validation.”
“I am delighted to welcome Denis to the EAS consulting team,” says EAS President Ed Steele. “His wide experience in validation will significantly boost our capacity as we expand our services.”
In Memory of Arthur A. Checchi
Arthur A. Checchi, founder of the company to which EAS Consulting Group traces its roots nearly half a century ago, died January 14 in Silver Spring, Md., from complications of Parkinson’s disease.
Mr. Checchi began his career as an FDA food inspector and went on to become Assistant Deputy Commissioner. He was one of the main architects of the 1958 Food Additives Amendment to the Federal Food, Drug, and Cosmetic Act. He left the agency in 1960 to establish his own food and drug regulatory consulting business, first as a division of his brother Vincent's consulting firm, Checchi and Company, and then as an independent entity, Arthur A. Checchi, Inc. The company earned an international reputation as a consulting firm specializing in FDA regulatory matters.
In 1985, Anthony C. Celeste, FDA’s Director of Regional Operations, assumed leadership of the company, operating it under the name AAC Consulting Group. In 2001 AAC was acquired by Kendle International. In 2006, Ed Steele, then president of AAC and vice president of Kendle Regulatory Affairs, acquired Kendle’s Division of Food, Dietary Supplement, and Cosmetic Consulting. At that time, he formed EAS Consulting Group as an independent company. In September 2007, EAS added pharmaceutical and medical device consulting to its list of services.
We honor Arthur Checchi (1922-2009) and offer condolences to his family and friends.
Climbing the Carew Tower
EAS is supporting a friend and former colleague, Dr. William Sietsema, vice president of clinical and regulatory strategic planning at Kendle International, in a unique fund-raising effort for the American Lung Association. On February 22, he will climb the 45-floor Carew Tower in downtown Cincinnati, Ohio—using the stairs.
The proceeds from Climb the Carew will fund research for better treatments, as well as education to reduce the impact of respiratory illness. It will also help support individuals with lung disease and their loved ones.
The association works to eradicate numerous lung diseases such as asthma, lung cancer, Chronic Obstructive Pulmonary Disease (emphysema and chronic bronchitis), cystic fibrosis and others.
For more details, or to support Bill’s effort, click here.
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Upcoming Events
Sign Up for the Free EAS GMP Challenge
It’s not too late to sign up for the free EAS GMP Challenge webinar, which will be presented February 5 at 2 p.m. EST.
Don’t wait until FDA begins enforcement of its final Dietary Supplement GMP regulations. Sign up and check your understanding of the new rule and take this opportunity to ask questions of FDA regulatory experts.
Webinar participants are invited to take a quick, confidential online quiz to assess their understanding of the new GMP requirements. They may also ask questions at that time—or during the live webinar—and our presenters will target their remarks to those issues.
Speakers for the free, 60-minute webinar will include Brad Williams, Manager of FDA’s Division of Dietary Supplement Programs, Carl Reynolds, EAS Vice President, and Ed Steele, EAS President. The seminar will be moderated by Jon Benninger of Virgo Publishing.
This is your chance to question the regulators on the details of the final rule on GMPs including its impact on laboratory operations. Click here to sign up for the webinar and take the EAS GMP Challenge.
Our GMP experts have conducted many gap assessment audits and they know the compliance issues that tend to be most misunderstood—sub-lot testing requirements for finished products, for example. EAS has scheduled a Dietary Supplement GMP Seminar, March 17-18, which will address 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 will hold a separate lab seminar, Ensuring Regulatory Compliance of Dietary Supplement Laboratories, March 19-20. This course will provide the knowledge and skills needed for GMP compliance of laboratories.
In addition to these scheduled events, our experts are available to conduct in-house seminars for individual organizations and to conduct gap assessment audits.
Food Labeling Compliance Review Seminar and Update
EAS is pleased to announce that Beatrice Greenberg, who recently retired as chief of the Labeling Regulations Implementation Team in FDA’s Center for Food Safety and Applied Nutrition, Robert Post, Deputy Director of USDA’s Center for Nutrition Policy and Promotion, and Diane McColl of the law firm Hymen, Phelps & McNamara, will join EAS consultants Gisela Leon and James Hoadley February 24-26 to share their thoughts during our Food Labeling Compliance Review Seminar and Update.
Instructors for the food labeling compliance review seminar, February 24-25, are senior consultants James Hoadley and Gisela Leon, along with Dr. Post. Dr. Hoadley is a former senior regulatory scientist in FDA’s Office of Nutritional Products, Labeling and Dietary Supplements with primary responsibilities in food label claim regulations. Gisela Leon is a consultant experienced in compliance of labeling for foods and dietary supplements. Dr. Post will discuss USDA’s latest thinking on labeling compliance issues during the two-day seminar.
In the February 26 special update, Ms. McColl will explain the implications of Section 912 for food labeling. In addition, Beatrice Greenberg, will discuss FDA’s enforcement priorities and will review the agency’s Nutrition Labeling and Education Act compliance program.
Also, the update will address other emerging issues and will include:
- A review of FDA warning letters issued in 2008.
- An update on label claims.
- The implications of FDA’s “no questions” response to two GRAS notifications for - Stevia derived sweeteners
- FDA’s December 2008 guidance to industry on front of package symbols.
Both the two-day seminar and the one-day update will be held at EAS headquarters, 1940 Duke Street, Alexandria, Va., from 8:00 a.m.–5:00 p.m. For more information, click here.
OTC Drug and Cosmetics Labeling Compliance Review Seminar
EAS is now taking reservations for our April 1-2 seminar on labeling compliance for OTC drugs and cosmetics. This is the first public presentation of a seminar which has previously been offered on an in-house basis.
Instructors for this event will be William (Bill) Schwemer, a former Associate Commissioner for Regulatory Affairs at FDA, and Norma Skolnik, whose career includes a decade as director of regulatory affairs for Cadbury Adams USA (formerly Pfizer’s Adams Division).
The event will be held in our headquarters at 1940 Duke Street, Alexandria, Va. Click here to sign up for our OTC Drug and Cosmetics Labeling Compliance Review Seminar.
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Order Publications and Regulatory Tools
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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
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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
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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
Hardbound book |
$ 184.99
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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 |
$ 209.99 / set
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