The American Herbal Products Association (AHPA) will present a two-hour educational teleseminar titled "FDA cGMP Inspections & Emerging Compliance Issues for Dietary Supplements," on Wednesday, Dec. 19, 2012, from 1 to 3 p.m. EST.
The Food and Drug Administration (FDA) has increased its regulatory activity related to the manufacture and distribution of dietary supplements, completing almost three times as many current good manufacturing practice (cGMP) inspections during 2011 as it did in 2010, according to recent reports. And the industry continues to be challenged by having to come into compliance with various regulations that are based on cGMP.
AHPA maintains the industry's largest repository of inspection data, including actual FDA 483 Inspection and Observation forms and establishment inspection reports (EIRs) and has used this information to create a detailed analysis of where FDA inspectors focus the majority of their attention during cGMP inspections.
This two-hour teleseminar is designed to provide the necessary information to help industry companies allocate their compliance resources. Industry experts will provide attendees with an insider's view of where FDA focuses its efforts during dietary supplement cGMP inspections to help participants fulfilling their all-important compliance efforts.
Participants will learn from industry experts about topics such as:
- 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 and how to respond to a Form FDA 483
Teleseminar presenters include:
- FDA legal expert Anthony Young of Kleinfeld, Kaplan & Becker and AHPA general counsel, who will discuss inspection preparedness and what to expect during a cGMP inspection, what aspects of the cGMP you are responsible for during an inspection, and how to use and understand available guidance.
- Former FDA regulatory chemist Seth Goldenberg Ph.D., who will discuss FDA warning letters and 483s, what to learn from them and how to respond, and general compliance strategies for small-, mid-, and large-sized businesses.
- AHPA Information Analyst Merle Zimmermann, Ph.D., who will provide a detailed analysis of recent FDA inspection reports, including a summary of the collection process, review of data, primary observations, and detailed examples.
A Q&A session will follow the speaker presentations to allow attendees to anonymously ask specific questions about FDA inspections and related matters.
This AHPA teleseminar will greatly benefit business owners, quality assurance and quality control personnel, facilities managers, compliance officers, legal and regulatory personnel, and laboratory managers.
The cost of the teleseminar is $195 for AHPA members and $495 for nonmembers. For more information and to register for the teleseminar, visit the AHPA website or contact Devon Powell, 301.588.1171 x102.