Partner Series—The EAS GMP Challenge

INSIDER Partner Series

Attend this free Webinar to hear FDA and GMP compliance experts from EAS Consulting discuss the most often misunderstood GMP issues and the steps you should be taking now to be in compliance. EAS consultants have been performing GMP gap analysis audits of dietary supplement manufacturers. Those assessments have revealed many companies still have a lot of work to do to achieve compliance by the June 2009 deadline for companies with 20-500 employees. Don't wait until FDA begins enforcement of its final Dietary Supplement GMP regulations!

Attend this free Webinar to ask questions and learn about:

• The most often misunderstood GMP compliance issues, such as setting specifications, establishing material review processes and the roles and responsibilities of quality control personnel
• The steps you should be taking right now
• The significance of the lab portion of GMPs
• Much more

Speakers:

Carl Reynolds, vice president of EAS Consulting Group, is one of the country's premier food and dietary supplement regulatory experts, with more than 44 years of U.S. Food and Drug Administration (FDA) and consulting experience. Reynolds' is a frequent speaker on Good Manufacturing Practice (GMP) issues at industry training events and conferences and has contributed to the activities of various supplement trade groups including by Natural Products Association, Council for Responsible Nutrition (CRN) and American Herbal Products Association (AHPA). He began his FDA career in 1962 as an investigator in FDA’s Denver district. He next served as resident in charge in the FDA's Albuquerque Resident Post. He served five years as a supervisory investigator in the Dallas District, 11 years as the director of the Investigations Branch in the Orlando District, and five years as the Detroit District Director. 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). Reynolds joined AAC/Kendle as a senior consultant in 1999 and became vice president of EAS Consulting Group in October 2006. He is an approved auditor for the Natural Products Association’s GMP Certification Program.

Edward A. Steele, president of EAS Consulting Group, spent 30 years at FDA, with responsibilities including management, development, planning and implementation of the CFSAN’s compliance programs. He began his agency career in 1964 as an analytical chemist in the New York District. He then moved to FDA Headquarters in Washington, D.C., where he held various positions of increasing responsibility at CFSAN. In 1994, he joined AAC/Kendle as vice president of the Food, Dietary Supplement and Cosmetic Consulting Division. 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 his last two years at AAC/Kendle, he served as president of the Rockville, Md., office. In October 2006 he formed EAS Consulting Group and now serves as president of this independent company.

Bradford W. Williams has been with the FDA for more than 25 years. He currently is the manager of the Division of Dietary Supplement Programs in the Office of Nutrition, Labeling and Dietary Supplements in CFSAN where he is instrumental in implementing the Dietary Supplement Current Good Manufacturing Practices regulations. In addition, he has been involved in developing the center's Dietary Supplement Regulatory Strategic Plan, heading the Enforcement/Safety Strategy Team, which developed regulatory policies and procedures for enforcement of the Dietary Supplement Health and Education Act. Williams earned his bachelor's degree in chemistry graduate from Curry College in Milton, Mass., and studied graduate-level chemistry at Boston College and Providence College.

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• The EAS GMP Challenge