Webinar Recording: cGMP Compliance: Botanical Identity & Herb Quality

Presented: September 28, 2006

$100.00
$50.00
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Published: Thursday, September 28, 2006

How you handle botanical ingredient identity and quality is key to the products you’re manufacturing. Designed for companies that want to evaluate their ingredient identity and quality assurance systems, and prepare for new demands expected to be in FDA’s dietary supplement GMP rule. The materials from this AHPA educational tele-seminar will help you understand FDA’s proposed rules and how industry responded — giving you both the maximum and minimum expected standards that are on the horizon. Making Good Manufacturing Practice a part of your process sooner, rather than later, will ease the burden of compliance when final cGMP rules are issued.

What you’ll learn from these experts:

  • Lynda Hammons,Vice-present of Quality and Regulatory Affairs at Nature’s Sunshine Products — gives practical advice on setting and using standards, how to set ingredient specifications and select vendors, and shares a practical Raw Materials Testing Criteria Flow Chart
  • Sidney Sudberg, DC, LAc, RH (AHG), Director of Alkemists Pharmaceuticals, Inc. — explains Good Laboratory Practice, quality control, various analytical techniques for ingredient characterization and standardization, and case studies.
  • Roy Upton, RH (AHG), Executive Director of the American Herbal Pharmacopoeia, Vice-president of the American Herbalists Guild — reviews the legal requirements and expectations, and details physical tests (macroscopic characterization, microscopy), chemical tests (HPTLC, HPLC, FTIR, NIR), methods validation, documentation, sampling

Materials in this packet include:

  • A practical Raw Materials Testing Criteria Flow Chart
  • Course Outline, Speakers’ Presentations & Bios
  • Transcript, including answers to questions posed by attendees
  • Audio file

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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