Webinar Recording: FDA Inspection Trends, cGMP Compliance Issues and Responding to an FDA 483

Legal experts provide an update on FDA inspections, emerging cGMP compliance issues, strategies for responding to an FDA 483 and answers to your specific questions

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Legal experts provide an update on FDA inspections, emerging cGMP compliance issues, strategies for responding to an FDA 483 and answers to your specific questions.

Event Details

Dates and Times: 
Part 1 Recorded Nov. 30
Part 2 Recorded Dec. 14

Cost:
$199 (AHPA Members)
$399 (Non-Members)

This webinar helps businesses in the dietary supplement industry understand the elements of current Good Manufacturing Practice regulations (21 CFR 111) that have been the primary focus of recent FDA inspections. This knowledge will assist business in 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.

Part 1 -- Recorded November 30

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, which includes actual FDA 483 inspection reports, observation forms, and establishment inspection reports (EIRs).

A 30-minute Q&A session answers attendees specific questions.

Part 2 -- Recorded December 14

An extended Q&A session addresses attendee questions. Legal experts then provide strategies for companies to effectively respond to an FDA 483 in order to avoid getting a Warning Letter. Learn tips for conducting an FDA inspection.

Topics

  • Own label distributors and contract manufacturers: What are the differences and what aspects of the cGMP are you responsible for during an inspection?
  • Own label distributors and contract manufacturers: What are the differences and what aspects of the cGMP are you responsible for during an inspection?
  • FDA inspection practices and what can be done to prepare
  • Detailed analysis of recent FDA inspection reports
  • Effectively responding to an FDA 483 so as to avoid a Warning Letter
  • FDA inspection do's and don'ts
  • Answers to your questions during the extended Q&A session

Presenters

  • Anthony L. Young, Esq., Partner, Kleinfeld, Kaplan and Becker, LLP / AHPA General Counsel
  • Alan Feldstein, Esq., Of Counsel, Collins Gann McCloskey & Barry PLLC
  • Merle Zimmermann, Ph.D., Information Analyst, AHPA

Presenters

  • Ali Abdel-Rahman, Ph.D., Supervisory Toxicologist, Center for Food Safety and Applied Nutrition (CFSAN), Food and Drug Administration (FDA)
  • Claire L. Kruger, Ph.D., D.A.B.T., President, Senior Director Regulatory Affairs, ChromaDex Spherix Consulting
  • Merle Zimmermann, Ph.D., Chief Information Analyst, AHPA
  • Will Woodlee, Esq., Partner, Kleinfeld, Kaplan and Becker, LLP (Q&A Only)
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