Published: Tuesday, December 18, 2018
Part I: Recorded Dec. 4
Part 2: Recorded Dec. 18
Duration: 2 hours (4 hours total)
Members - $199
Non-Members - $399
This webinar is designed to help businesses in the dietary supplement industry understand the elements of current Good Manufacturing Practice (cGMP) regulations (21 CFR 111) that have been the primary focus of recent FDA inspections. This knowledge will assist business in better allocating and directing their compliance resources.
This two-part webinar provides data on recent FDA inspections, an overview of emerging compliance issues and strategies for responding to an FDA 483 in order to avoid an FDA warning letter.
Veteran industry legal experts provide an insider’s view of the current cGMP enforcement landscape and strategies for compliance. AHPA staff offer a detailed analysis of the association’s repository of inspection data, widely regarded as the most in-depth in the industry. This analysis includes actual FDA 483 inspection reports, observation forms, and establishment inspection reports (EIRs). A summary of the collection process, a review of the data and detailed examples will also be provided.
A 30-minute Q&A session follows the speaker presentations to answer specific questions about FDA inspections, enforcement actions, and related matters.
An extended Q&A session addresses attendee questions. Legal experts will then provide strategies for companies to effectively respond to an FDA 483 in order to avoid getting a Warning Letter. Tips for conducting an FDA inspection will are also provided.
2019 Annual Fund Sponsors
AHPA appreciates the support of its sponsors, but does not endorse, recommend, or provide a warranty for any sponsor company, its products or services. AHPA has no responsibility for any transaction entered into with any of these companies.