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

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

Nov. 30 (FDA Inspections and Emerging cGMP Compliance Issues) -- Dec. 14 (Q&A and Responding to an FDA 483)

Published: Wednesday, October 25, 2017

Event date: 11/30/2017 1:00 PM - 3:00 PM Export event

Experts to 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: 
Nov. 30 -- 1:00-3:00 PM EST
Dec. 14 -- 1:00-3:00 PM EST

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

This webinar is designed to help 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 will provide 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 -- November 30

Veteran industry legal experts will provide an insider's view of the current cGMP enforcement landscape and strategies for compliance. AHPA staff will 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 20-30-minute Q&A session will answer attendees specific questions.

Part 2 -- December 14

An extended Q&A session will give attendees the opportunity to have their questions answered by the expert panel. Legal experts will then provide strategies for companies to effectively respond to an FDA 483 in order to avoid getting a Warning Letter. Attendees will also 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
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