(December 19, 2007, Silver Spring, MD) — The new AER law is about to go into effect, cGMP regs are on the horizon, and AHPA is ready to help with materials from its recent tele-seminars. If you missed these focused, practical courses when they were first offered, you can still benefit from the expert speakers by purchasing the course materials, transcripts and audio CDs. These useful additions to your training programs offer vital insights and tools that will ease coming into compliance with the new regulations.
To ensure you have the knowledge and tools to comply and stay in business, rely on AHPA’s expertise. AHPA’s web-based bookstore offers course details and secure, easy, online ordering all of AHPA’s educational courses: www.ahpa.org/Default.aspx?tabid=68.
Adverse Event Reporting: Strategies for Compliance
Come Saturday, December 22, dietary supplement manufacturers will be required to file serious adverse event reports (AERs) with the FDA, but you’ll be ready with AHPA’s strategic regulatory, medical and legal perspectives. In addition to reviewing the regulation and FDA’s guidance document, AHPA provides practical documents and insights from expert speakers.
Support documents to help your company comply with the law include:
♦ AHPA’s instructive form to record complete and thorough AER information
♦ “AER vs. Customer Complaint” — a decision-making flow chart
♦ Mandatory MedWatch form and facsimile MedWatch form
♦ “Quick Glance Advice about Mandatory Reporting”
Understanding the new cGMP regs is easier with insight and advice from AHPA. Presenters include industry and legal experts and the head of the FDA dietary supplement program that wrote the new regulations. Course materials include AHPA’s Annotated Final Rule on Dietary Supplement cGMP, which presents key points and comments made by FDA in the rule’s preamble next to the relevant sections. The preamble, or introduction to the rule by FDA, runs to 192 pages (the final rule itself is only 17 pages) and provides details that are critical to understanding how to comply.
“I really believe that anyone in the dietary supplement industry should read the whole preamble as it provides context and explains the logic behind the rule,” said Vasilios H. Frankos, MS, PhD, director of Division of Dietary Supplement Programs in the FDA's CFSAN, who also presented in this course. “AHPA’s annotated version provides a good synopsis of the preamble and makes understanding the rule much easier.”
Accompanying support documents include:
♦ AHPA’s Annotated Final Rule on Dietary Supplement cGMP
♦ Copies of the cGMP rules as published in 2003 and 2007
♦ Comparison of current good manufacturing practice regulations
Debriefing the FDA’s cGMP Implementation Seminar
Perhaps the only thing worse than waiting so long for the cGMP regs for dietary supplements is the conflicting interpretations and confusion that resulted. In October 2007, four months after publishing the cGMP regulations, the FDA held a multi-media educational event for stakeholders, Overview of the Implementation of the Current Good Manufacturing Practices for Dietary Supplements Guidance for Industry. During that event, FDA gave some interesting — and sometimes surprising — insight into how they intend to implement the new rules. Afterwards, in this seminar AHPA debriefed the industry with answers and the insight you need to comply with the regs and stay in business!
Course materials include:
♦ Audio CD of the AHPA event
♦ An unedited transcript of the AHPA event
♦ Links to the archived webcast
Stay tuned for details about AHPA’s upcoming educational events,
including one in January: Good Agricultural and Collection Practices!
The American Herbal Products Association (AHPA) is the only national trade association devoted to herbal issues. Representing the core of the botanical trade—comprised of the finest growers, processors, manufacturers and marketers of herbal products—our mission is to promote the responsible commerce of herbal products. AHPA committees generate self-regulations to ensure the highest level of quality with respect to the way herbal products are manufactured, labeled, and sold. Celebrating our 25th anniversary in 2007! Website: www.ahpa.org.