Teleseminar materials, including audio recordings, PowerPoint presentations, and related files for two recent American Herbal Products Association (AHPA) teleseminars are now available for purchase at the AHPA online bookstore.
"FDA cGMP Inspections & Emerging Compliance Issues for Dietary Supplements," held on Dec. 19, 2012, addressed the recent increase in Food and Drug Administration (FDA) current good manufacturing process (cGMP) inspections and how businesses in the supplement industry can best allocate their compliance resources to avoid Form 483 observation reports and warning letters.
Industry regulatory experts, including AHPA General Counsel Anthony Young of Kleinfeld, Kaplan & Becker LLP, and former FDA regulatory chemist Seth Goldenberg, Ph.D., of Asia Pacific Bio Intelligence, who performed cGMP inspections of pharmaceutical and dietary supplement firms while at FDA, discussed inspection preparedness and what to expect during a cGMP inspection, what you're responsible for during an inspection, using and understanding available guidance, what 483s and warning letters teach and how to respond, including general compliance strategies for small-, mid-, and large-sized businesses.
Additionally, AHPA Information Analyst Merle Zimmermann, Ph.D., shared a review and detailed analysis of 263 establishment inspection reports, as well as 483 forms, providing attendees with an understanding of where FDA inspectors have focused the majority of their attention during recent cGMP inspections and how businesses can learn from the data in order to prepare for an inspection in advance.
Conducted on Oct. 25, 2012, AHPA's "Marketing Red Flags for Dietary Supplements" teleseminar focused on a number of regulatory compliance challenges that the dietary supplement industry encounters in its efforts to navigate regulatory compliance while creating successful product marketing, including labels, websites, and other promotional materials.
Speakers included representatives from FDA and the Federal Trade Commission, who outlined their agencies' regulatory authority and discussed recent regulatory actions.
Participants also heard from attorneys with expertise in the field of food and drug law, including the corporate counsel for market leader Amway about how its legal and marketing departments work together to craft compliant and potent marketing, labeling, and related information.
Highlights of this 135-minute teleseminar include:
- How compliance with FDA doesn't always mean compliance with FTC
- Who is liable for third-party claims
- How to avoid labeling violations that are contradictory and misleading
- Explicit and implicit claims--how to avoid being investigated
A suite of additional documents and resources, including various FDA- and FTC- claims-related documents accompanies the audio recording and PowerPoint presentation for this educational seminar.
For more information about each teleseminar, visit the AHPA online bookstore or contact Devon Powell, 301.588.1171 x102.