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present
“The Webinar: CRN’s Overview of Dietary Supplement GMPs”
This Webinar will educate and inform industry about FDA’s final rule on Good Manufacturing Practices (GMPs) for dietary supplements, and cover critical issues and concerns.
Available: On Demand
Topics to be covered include:
- A general overview of the final ruling
- A side-by-side comparison of the FDA final rule and FDA proposed rule
- An in-depth discussion of major requirements
- General impressions of the regulation and its implications: Legal perspective
- Finished product sampling plans and critical control points (CCPs)
- Certificates of Analysis
- Expiration dating, equipment validation and standard operating procedures (SOPs)
- Special issues for ingredients
- Questions and Answers for FDA
Speakers include:*
- Annette Dickinson, Ph.D., CRN past president and consultant
- Bill H. Frankos, Ph.D., director of Division of Dietary Supplement Programs (DDSP), FDA
- Eugene Lambert, senior counsel, food and drug practice, Covington & Burling
- Paul Bolar, CRN board member and Regulatory Affairs Committee co-chairperson, vice president of Pharmavite
- Joy Joseph, industry consultant
- Kevin Boot, regulatory counsel, Embria Health Sciences
- Michael Bradley, director nutritional scientific affairs for the Perrigo Company
- David R. Schoneker is the director of global regulatory affairs at Colorcon
To view presenter bios, click here
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