The American Herbal Products Association (AHPA) will present a Tele-Seminar to cover the fundamentals of establishing a Consumer Complaint / Adverse Event Reporting system for dietary supplement product manufacturers. In less than two hours, participants will know the answers to these questions, and what to do about them:
• What is an adverse event, and what is a serious adverse event?
• How are they different from consumer product complaints?
• What are the legal issues?
• How should consumer calls be handled?
• What questions should be asked?
• Who should ask them?
• How should reports be tracked?
• What kind of follow-up should be done?
Experts will explain the important regulatory and legal issues, key elements of a tracking system, and specific steps to follow. A well-controlled consumer complaint and adverse event reporting system may decrease product liability, and the likelihood or impact of lawsuits and other regulatory sanctions. The proposed CGMPs call for an internal process to track complaints about product quality and manufacturing procedures. Information from AHPA’s AER Tele-Seminar will help companies establish an AER process that will fit their unique needs.
A convenient and cost-effective way to explore issues, gain insight, and enhance knowledge, the Tele-Seminar is a live telephone conference call. AHPA is offering this introductory Tele-Seminar at a reduced “preview” price. Each attendee will receive a Certificate of Completion, which will be an important addition to GMP training and personnel files.
Two identical sessions are scheduled to start at 1 p.m. EDT on May 11 or May 20, 2004. Each seminar will be limited to just 30 call lines, but unlimited staff members may listen on a speaker phone. The seminar costs $30 per connection for AHPA member companies, and $45 per connection for non-member companies. Optional transcripts cost an additional $10. Register via email to Natasha Hall at [email protected].
The American Herbal Products Association (AHPA) is the national trade association and voice of the herbal supplement industry. Founded in 1983, AHPA is the recognized leader in representing the responsible center of the botanical trade, and is comprised of the finest growers, processors, manufacturers and marketers of herbal products.