- An overview of issues purchasers and manufactures should consider:
- What information is needed to prepare a manufacturing quote?
- How should specifications be set?
- How are record keeping and quality control tasks assigned?
- Regulatory requirements for each party:
- What does FDA expect during inspections?
- How do the inspection obligations of the contract manufacturer differ from those of the own label distributor?
- What manufacturing records should a distributor retain?
- Who has responsibility for customer complaints and adverse events?
- Insights from veterans from both sides (manufacturers and distributors)
- Answers to participants' questions by an FDA official and legal and industry experts
Tony Young -- Partner at Kleinfeld, Kaplan and Becker, LLP, and AHPA General Counsel
Cara Welch -- Team Leader of the Dietary Supplements Regulations Implementation Team in the Division of Dietary Supplement Programs at the U.S. Food and Drug Administration (FDA)
David Morrison -- Vice President of Scientific and Regulatory Affairs at Vitamin Shoppe
Richard Kaufman -- Chief Operating Officer at Paragon Laboratories
Mitch Coven -- President of Vitality Works, Inc.
Michael McGuffin -- President of AHPA
- MP3 Audio file recording of the two-hour webinar
- White paper: The Relationship Between Dietary Supplement Contract Manufacturers and Packagers and their Customers -- DRAFT
- White paper: Records Requirements for Contract Manufacturers, Packagers and Distributors of Dietary Supplements -- DRAFT
- Checklist: Assigning responsibilities for contract manufacturers and their customers
- Sample distributor Request for Quote from a contract manufacturer
- Annotated Final Rule on Dietary Supplement cGMP
- Presenters’ slides
Webinar Recording Details
Presented: March 22, 2016
Duration: Two hours
Cost: $220 - AHPA Members
- Video Recording (MP4)
- Presenter Slides
- AHPA Microbial Level Chart
- Speaker 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.