AHPA has the largest repository of inspection data from actual 483's, EIR's, and other sources, and has created a detailed analysis of where FDA inspectors are focusing the majority of their attention during dietary supplement cGMP inspections. New, small-to-mid, and large businesses will benefit from this information as it will provide guidance on what areas to best focus compliance resources.
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?
- Detailed analysis of recent FDA inspection reports
- What the inspection reports teach & how to respond to a 483
As always, a significant portion of the seminar will be dedicated to answering YOUR SPECIFIC questions!
Tony Young, Esq., Kleinfeld, Kaplan & Becker
Mr. 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 the Food and Drug Administration and he currently serves as General Counsel to the American Herbal Products Association (AHPA).
Marian Boardley, Marian Boardley Consulting
Marian Boardley is an independent consultant who manages cGMP projects for dietary supplement manufacturers and distributors. Marian is also currently a Senior Consultant with FDA Compliance Group LLC. She advises several clients in the food, drug, and dietary supplement industries in good manufacturing practices and legal compliance. She regularly trains staff to be ready for FDA inspections and also writes SOP's in good manufacturing practices. Ms. Boardley recently spent over two years managing GMP compliance and the botanical identity program for a Utah-based dietary supplement company.
Merle Zimmermann, Ph.D., Information Analyst, AHPA
Merle 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 docotorate in analytical chemistry, Merle has been an invaluable addition to the AHPA staff.
Save time and money with NO travel costs - and have as many employees attend as you can fit around your conference room or office speakerphone.
Who should attend?
Business owners, QA/QC/Safety personnel, Facilities Managers, Compliance Officers, Legal/Regulatory Personnel, Laboratory Managers