Webinar Recording: cGMP Compliance Series Teleseminar: Variances

Customer complaints, product returns, out-of-specification lab results, calibration failures, manufacturing deviations … all of these are serious issues no business in the dietary supplement industry wants to face. But variances--an exception or departure from approved protocol--occur and have to be prepared for and managed under dietary supplement cGMP. The cGMPs apply to all domestic and foreign companies that manufacture, package, label, or hold dietary supplements, including those involved with the activities of testing, quality control, packaging and labeling, and distribution in the United States.

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Under FDA regulations for cGMPs, variances must be detected, investigated, documented, explained, and addressed. With the right guidance, information, and tools, the process is much easier.


This AHPA educational teleseminar and accompanying standard operating procedure (SOP) templates (more than 30 are included) will assist dietary supplement marketers, manufacturers, distributors, and suppliers with a thorough understanding of the following key variance issues:

  • FDA regulations and how they apply to your business
  • A review of variance issues with practical guidance on how to address them from a panel of industry cGMP experts. Topics include:
  • Customer complaints and product returns
  • Out-of-specification investigations
  • Corrective and preventative actions
  • Product recalls
  • Reportable foods, recordkeeping, and SOPs

Materials in this packet include:

 

  • Teleseminar presentation files
  • Teleseminar audio file
  • More than 30 fully customizable examples of SOP reports and log forms, including:
  • Unplanned Events
  • Calibration Failures
  • Nonconforming Materials
  • Planned Deviations
  • Production Failure
  • Corrective & Preventative Actions
  • Out-of-specification Investigations
  • Customer Complaints
  • Returned Goods
  • Reportable Foods
  • Recall Procedure

Member Price: $220.00
Non-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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