Webinar Recording: FDA cGMP Inspections & Emerging Compliance Issues for Dietary Supplements

The Food and Drug Administration (FDA) has increased its regulatory activity related to the manufacture and distribution of dietary supplements, completing almost three times as many current good manufacturing practice (cGMP) inspections during 2011 as it did in 2010, according to recent reports. And the industry continues to be challenged by having to come into compliance with various regulations that are based on cGMP.

AHPA maintains the industry's largest repository of inspection data, including actual FDA 483 Inspection and Observation forms and establishment inspection reports (EIRs) and has used this information to create a detailed analysis of where FDA inspectors focus the majority of their attention during cGMP inspections.

This two-hour teleseminar is designed to provide the necessary information to help industry companies allocate their compliance resources. Industry experts will provide attendees with an insider's view of where FDA focuses its efforts during dietary supplement cGMP inspections to help participants fulfilling their all-important compliance efforts.

$520.00
$220.00
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Presenters and Topics:

Anthony Young, Kleinfeld, Kaplan & Becker 

Anthony Young has extensive expertise in all matters relating to the administration of the Federal Food, Drug, and Cosmetic Act and related laws. He represents food, drug, and dietary supplement product and ingredient manufacturers, developers, and distributors. Mr. Young has represented various trade associations before FDA, and he currently serves as general counsel to the American Herbal Products Association (AHPA). Mr. Young presented information on the following topics:

  • Inspection preparedness and what to expect during a cGMP inspection
  • 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?
  • Using and understanding available guidance

Former FDA Regulatory Chemist Seth Goldenberg, Ph.D.

Dr. Goldenberg is a former regulatory chemist with FDA, who performed cGMP inspections of pharmaceutical and dietary supplement firms in addition to executing bench work to ensure that products were meeting appropriate standards. He is currently working with Asia Pacific Bio Intelligence, which provides regulatory and quality consulting for firms in the United States and China, assisting them with overcoming hurdles and resolving issues with regulatory bodies such as the U.S. FDA and Chinese State Food and Drug Administration. He discussed the following topics:

  • FDA Warning Letters and 483s: What they teach and how to respond, including general compliance stragegies for small-, mid-, and large-sized businesses

Merle Zimmermann, Ph.D., AHPA Information Analyst

Dr. Merle Zimmermann has been spearheading the collection and analysis of information on FDA inspections and related documentation for AHPA and is initimately familar with 21 CFR 111. A graduate of the University of Maryland with a doctorate in analytical chemistry, Dr. Zimmermann presented infomartion on the following topic:

  • Detailed analysis of recent FDA inspection reports, including a summary of the collection process, review of data, primary observations, and detailed examples.

Materials in this packet include:

  • Teleseminar presentation files
  • Teleseminar audio fille

Member Price: $220.00Non-Member Price: $520.00

Print

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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