On February 23, 2012, the American Herbal Products Association (AHPA) hosted the teleseminar "FDA cGMP Inspections & Emerging Compliance Issues for Dietary Supplements." Materials from this event are now available for purchase at AHPA's online bookstore.
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 information in the teleseminar provides companies of all sizes specific guidance to help them allocate appropriate compliance resources.
The teleseminar featured a panel of industry experts, who described where FDA has been focusing its efforts during dietary supplement cGMP inspections to assist participants in fulfilling their all-important compliance efforts.
The AHPA teleseminar includes topics such as:
- 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?
- Detailed analysis of recent FDA inspection reports
- What the inspection reports teach and how to respond to a Form 483
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.
The teleseminar materials include all the presentation files and a complete audio file. AHPA members receive a substantial discount.