The Food and Drug Administration (FDA) has increased its regulatory activity related to the manufacture and distribution of dietary supplements, completing almost three times as many current good manufacturing practice (cGMP) inspections during 2011 as it did in 2010, according to recent reports. And the industry continues to be challenged by having to come into compliance with various regulations that are based on cGMP.
AHPA maintains the industry's largest repository of inspection data, including actual FDA 483 Inspection and Observation forms and establishment inspection reports (EIRs) and has used this information to create a detailed analysis of where FDA inspectors focus the majority of their attention during cGMP inspections.
This two-hour teleseminar is designed to provide the necessary information to help industry companies allocate their compliance resources. Industry experts will provide attendees with an insider's view of where FDA focuses its efforts during dietary supplement cGMP inspections to help participants fulfilling their all-important compliance efforts.
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
Former FDA Regulatory Chemist Seth Goldenberg, Ph.D.
Dr. Goldenberg is a former regulatory chemist with FDA, who performed cGMP inspections of pharmaceutical and dietary supplement firms in addition to executing bench work to ensure that products were meeting appropriate standards. He is currently working with Asia Pacific Bio Intelligence, which provides regulatory and quality consulting for firms in the United States and China, assisting them with overcoming hurdles and resolving issues with regulatory bodies such as the U.S. FDA and Chinese State Food and Drug Administration. He discussed 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 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:
Member Price: $220.00
- Teleseminar presentation files
- Teleseminar audio fille
Non-Member Price: $520.00