Webinar Recording: FDA Inspections & Emerging cGMP Compliance Issues

The American Herbal Products Association (AHPA) presented a two-hour educational teleseminar, “FDA Inspections and Emerging cGMP Compliance Issues for Dietary Supplements,” on Thursday, May 15, 2014.

A regularly occurring event and part of the association’s cGMP Compliance Series, this two-hour, audio-only teleseminar is designed to help businesses in the dietary supplement industry understand the elements of 21 CFR 111/current Good Manufacturing Practices (cGMP) regulations that are most focused on during recent FDA inspections. This knowledge will assist business with better allocating their compliance resources.

Veteran industry legal experts provide attendees with an insider’s view of current cGMP enforcement landscape. AHPA staff offers a detailed analysis of the association’s repository of inspection data, widely regarded as the most in-depth in the industry and which includes actual FDA 483 Inspection reports, Observation forms, and establishment inspection reports (EIRs).

$520.00
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Topics

  • 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?
  • FDA “Hot buttons” during inspections and what can be done to prepare and mitigate 
  • Detailed analysis of recent (2013-present) FDA inspection reports
  • What the inspection reports teach and how to appropriately respond to a Form FDA 483
  • Answers to your questions during the Q&A session

Presenters

  • FDA legal expert panel:
    • Tony Young, Kleinfeld, Kaplan & Becker/AHPA General Counsel
    • Justin Prochnow, Greenberg Traurig
    • Ashish Talati, Amin Talati
    • Marc Ullman, Ullman, Shapiro & Ullman
  • AHPA Information Analyst Merle Zimmermann, Ph.D., who will provide a detailed analysis of recent FDA inspection reports, including a summary of the collection process, review of data, primary observations, and detailed examples.

A 20-30 minute Q&A session follows the speaker’s presentations to answer specific questions about FDA inspections, enforcement actions, and related matters. 

Cost

 

  • AHPA Members: $220.00
  • Nonmembers: $520.00
  1. Bios

The Botanical Safety Handbook, Second Edition includes:

  • Easily understood classification systems to indicate the safety of each listed species and the potential for drug interactions
  • Information on adverse events reported in clinical trials or case reports 
  • Safety-related pharmacology and pharmacokinetics of each herb
  • Additional information on the use of herbs by pregnant or lactating women 
  • Toxicological studies and data on toxic compounds 
  • Extensive references for each entry

The book is available in hardback print and online formats. Both versions contain the same information, but the online version, which is optimized for smartphones and tablets, has several additional attributes. Some of these relate to its operation, as it allows subscribers to search for keywords and botanical names and easily access the information they use most by saving personalized lists of entries. Perhaps more importantly, the online version will be updated regularly with new research, and subscribers will be notified of updates to provide immediate access to the most current information. The standard retail cost for either version is $119.95 (one-time cost in print; a renewable annual subscription online). We are discounting the cost for our members and would be happy to offer a discount to other organizations. A free preview of several entries are available online:

Subscribe to the online version or purchase a hardcover copy today. AHPA's Botanical Safety Handbook, Second Edition  Print Version: 1,042 pages, revised edition published in 2013 AHPA's Botanical Safety Handbook, Second Edition Online

Member annual subscription: $95.00 
Non-member annual subscription: $119.00 Discounts available for multiple user subscriptions.

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