The American Herbal Products Association (AHPA) is producing a new teleseminar: "FDA cGMP Inspections & Emerging Compliance Issues" on Thursday, Feb. 23, at 1 p.m. EST. The two-hour teleseminar is open to all industry companies; AHPA members will receive a substantial registration discount.
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 process (cGMP), and suppliers are challenged by having to come into compliance with a new rule that is essentially based on a drug GMP.
Attendees to this teleseminar will learn from a panel of industry experts where FDA has been focusing its efforts during dietary supplement cGMP inspections to assist participants in fulfilling their all-important compliance efforts.
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.
This information will provide companies of all sizes specific guidance to help them allocate appropriate compliance resources. The teleseminar is geared toward business owners, quality assurance/quality control/safety personnel, facilities managers, compliance officers, legal/regulatory personnel, and laboratory managers.
In addition, the AHPA teleseminar will provide attendees with presentations from experts on 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
A significant portion of the teleseminar will be allocated to answering participant questions.