FDA Inspections & Emerging cGMP Compliance Issues for Dietary Supplements

AHPA Updates

FDA Inspections & Emerging cGMP Compliance Issues for Dietary Supplements

Published: Thursday, September 10, 2015

The American Herbal Products Association (AHPA) will present a two-hour educational webinar titled "FDA Inspections & Emerging cGMP Compliance Issues for Dietary Supplements--Recent 483s," on Thursday, October 1, 2015, from 1:00-3:00 p.m. EDT. 

A regularly occurring event and part of the association's cGMP Compliance Series, this two-hour webinar is designed to help those businesses in the dietary supplement industry understand the elements of 21 CFR 111/current good manufacturing practice (cGMP) regulations that are most focused on during recent FDA inspections. This knowledge will assist businesses with better allocating their compliance resources. 

Veteran industry legal experts will provide attendees with an insider's view of current cGMP enforcement landscape. AHPA staff will offer a detailed analysis of recently released inspection records, widely regarded as the most in-depth in the industry and includes FDA warning letters, 483 observation forms, and establishment inspection reports. 

Topics will include:
Is FDA raising the bar on product specifications and testing?
What aspects of the cGMP are you responsible for during an inspection? 
FDA "hot buttons" during inspections and what can be done to prepare as well as mitigate  
Detailed analysis of recent FDA inspection reports 
What to learn from inspection reports and how to appropriately respond to a FDA Form 483
What goes wrong after it all goes wrong?  
A 20-30 minute Q&A session will follow the speaker's presentations to allow attendees to anonymously ask specific questions about FDA inspections, enforcement actions, and related matters.
 
All registrants will receive a recording of the live event and all presentation materials.
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