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Dietary Supplement GMPs – The Fallout

Brought to you by:

Orange County Regulatory Affairs Discussion Group (OCRA)

Natural Products Association

This session would begin with an overview of the impact of the Dietary Supplement Health and Education Act (DSHEA), the most significant legislation for dietary supplement companies, briefly outlining implementing regulations and touch on current hot topics related to DS (adulterated products / disease claims / GMPs).

The primary focus of the session will be an update on the GMPs.  It’s been over three years since FDA published their final GMP rule for dietary supplements.  This portion of the program will include a brief overview of the rule, look at the focus of the FDA GMP inspections as well as discuss several current hot GMP topics: qualifying suppliers, establishing specifications, testing and laboratory requirements, master manufacturing records, and tips for surviving FDA inspections.

Meeting Flyer

For more details, download the meeting flyer here. 

Program Manager

Vicki Whitsitt, Manager, Scientific and Regulatory Affairs - Natural Products Association

Presenters

Daniel Fabricant, Ph.D., VP of Scientific and Regulatory Affairs, Natural Products Association

Cindy Beehner, President, QSD Consulting (regulatory consultant for food, drug and dietary supplement industries)

FDA Speaker Invited

Schedule

5:30 – 6:30 pm     Registration/Networking and Dinner
6:30 – 9:00 pm     Presentations
9:00 – 9:30 pm     Questions and Answers

Location  

Abbott Medical Optics (AMO)
1700 E. St. Andrew Place, Santa Ana, CA  92705
(714) 247-8200

Registration Rates

$50 - OCRA Members

$50 - NPA Members

$100 - Non-Members (includes OCRA membership through end of 2010)

$25 - Government and Students

Free - Employees of Abbott Medical Optics (as the host facility)

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