WHAT YOU CAN EXPECT TO LEARN
Representatives from the Food and Drug Administration (FDA) have recently indicated that the most important issue for the dietary supplement industry is to comply with current good manufacturing practice (cGMP), and suppliers are challenged by having to come into compliance with a new rule that is essentially based on a drug GMP.
The American Herbal Products Association (AHPA) maintains the largest repository of inspection data from actual Form FDA 483s or "Inspectional Observations," establishment inspection reports (EIRs), and other sources and has created a detailed analysis of where FDA inspectors focus their attention during these inspections.
Attendees to this teleseminar will learn from a panel of industry experts where FDA has been focusing its efforts during dietary supplement cGMP inspections to assist participants in fulfilling their all-important compliance efforts.
And perhaps most importantly--get answers to YOUR SPECIFIC QUESTIONS during the Q&A portion of the event!
PRESENTERS & TOPICS
Anthony Young, Kleinfeld, Kaplan & Becker
Anthony Young has extensive expertise in all matters relating to the administration of the Federal Food, Drug, and Cosmetic Act and related laws. He represents food, drug, and dietary supplement product and ingredient manufacturers, developers, and distributors. Mr. Young has represented various trade associations before FDA, and he currently serves as general counsel to the American Herbal Products Association (AHPA).
Mr. Young will be presenting information on the following topics:
· Inspection preparedness and what to expect during a cGMP inspection
· Manufacturer vs. contract manufacturer vs. supplier vs. brand marketer: What are the differences and what aspects of the cGMP are you responsible for during an inspection?
· Using and understanding available guidance
Marian Boardley, Marian Boardley Consulting
Marian Boardley is an independent consultant who manages cGMP projects for dietary supplement manufacturers and distributors. Ms. Boardley is also currently a senior consultant with FDA Compliance Group LLC. She advises several clients in the food, drug, and dietary supplement industries in cGMPs and legal compliance. She regularly trains staff to be ready for FDA inspections and also writes standard operating procedures in good manufacturing practices. Ms. Boardley recently spent over two years managing cGMP compliance and the botanical identity program for a Utah-based dietary supplement company.
Ms. Boardley will be presenting information on the following topics:
- FDA Warning Letters and 483s: What they teach and how to respond, including general compliance strategies for small-, mid- and large-sized business
Merle Zimmermann, Ph.D., Information Analyst, AHPA
Dr. Merle Zimmermann has been spearheading the collection and analysis of information on FDA inspections and related documentation for AHPA and is initimately familar with 21 CFR 111. A graduate of the University of Maryland with a doctorate in analytical chemistry, Dr. Zimmermann has been an invaluable addition to the AHPA staff and will be providing a detailed analysis of the FDA inspections.
Dr. Zimmermann will be presenting information on the following topics:
- Detailed analysis of recent FDA inspection reports, including a summary of the collection process, review of data, primary observations, and detailed examples.
ATTENDANCE IS EASY!
Save time and money with no travel costs--and have as many employees attend as you can accommodate around your conference room or office speakerphone. As this is an audio-only event, all you need is a telephone connection to attend!
Who should attend?
This AHPA teleseminar will greatly benefit business owners, QA/QC/safety personnel, facilities managers, compliance officers, legal/regulatory personnel, and laboratory managers.
Click here to register.