This webinar is designed to help businesses in the dietary supplement industry understand the elements of 21 CFR 111 / current Good Manufacturing Practices (cGMP) regulations that have been the focus of recent FDA inspections. This knowledge will assist business to ascertain their own compliance status.
Veteran industry legal experts will provide attendees with an insider's view of the current cGMP enforcement landscape. AHPA staff will offer a detailed analysis of the association's repository of inspection data, widely regarded as the most in-depth in the industry. That analysis is based on actual FDA 483 Notices of Observations and establishment inspection reports (EIRs). A summary of the AHPA's data collection process, a review of the data and detailed examples will also be provided.
A 20-30-minute Q&A session will follow the speaker presentations to answer specific questions about FDA inspections, enforcement actions, and related matters.