||FDA cGMP Inspections & Emerging Compliance Issues for Dietary Supplements Teleseminar
February 23, 2012
Representatives from the Food and Drug Administration (FDA) have recently indicated that the most important issue for the dietary supplement industry is to comply with current good manufacturing practice (cGMP), and suppliers are challenged by having to come into compliance with a new rule that is essentially based on a drug GMP.
The American Herbal Products Association (AHPA) maintains the largest repository of inspection data from actual Form FDA 483s or "Inspectional Observations," establishment inspection reports (EIRs), and other sources and has created a detailed analysis of where FDA inspectors focus their attention during these inspections.
Presenters and Topics:
Anthony Young, Kleinfeld, Kaplan & Becker
Anthony Young has extensive expertise in all matters relating to the administration of the Federal Food, Drug, and Cosmetic Act and related laws. He represents food, drug, and dietary supplement product and ingredient manufacturers, developers, and distributors. Mr. Young has represented various trade associations before FDA, and he currently serves as general counsel to the American Herbal Products Association (AHPA). Mr. Young presented information on the following topics:
- Inspection preparedness and what to expect during a cGMP inspection
- Manufacturer vs. contract manufacturer vs. supplier vs. brand marketer: What are the differences and what aspects of the cGMP are you responsible for during an inspection?
- Using and understanding available guidance
Marian Boardley, Marian Boardley Consulting
Marian Boardley is an independent consultant who manages cGMP projects for dietary supplement manufacturers and distributors. Ms. Boardley is also currently a senior consultant with FDA Compliance Group LLC. She advises several clients in the food, drug, and dietary supplement industries in cGMPs and legal compliance. She regularly trains staff to be ready for FDA inspections and also writes standard operating procedures in good manufacturing practices. Ms. Boardley recently spent over two years managing cGMP compliance and the botanical identity program for a Utah-based dietary supplement company. Ms. Boardley presented information on the following topics:
FDA Warning Letters and 483s: What they teach and how to respond, including general compliance stragegies for small-, mid-, and large-sized businesses
Merle Zimmermann, Ph.D., AHPA Information Analyst
Dr. Merle Zimmermann has been spearheading the collection and analysis of information on FDA inspections and related documentation for AHPA and is initimately familar with 21 CFR 111. A graduate of the University of Maryland with a doctorate in analytical chemistry, Dr. Zimmermann has been an invaluable addition to the AHPA staff and will be providing a detailed analysis of the FDA inspections. Dr. Zimmermann presented infomartion on the following topic:
- Detailed analysis of recent FDA inspection reports, including a summary of the collection process, review of data, primary observations, and detailed examples.
Materials in this packet include:
- Teleseminar presentation files
- Teleseminar audio fille
Member Price: $220.00
Non-Member Price: $520.00
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