cGMP compliance for dietary supplements is mandated by FDA regulation 21 CFR part 111, which stipulates that anybody who produces, packages, labels, or holds a dietary supplement must create and implement current Good Manufacturing Practices (cGMPs) to ensure the supplement's quality. An FDA inspection is always imminent in a regulated industry. Their causes vary from receiving unknown SAERs to a scheduled visit. Regardless of the cause, the result is the same: THE FDA IS COMING.
We need to be prepared and “Audit Ready” so that their visit does not cause panic. This training will review the basic principles of an FDA inspection and give you tools to navigate the experience.Areas Covered in the Webinar:
VP of Quality & Product Development, Dietary Supplement Experts, LLC
Andy Swenson has been in the dietary supplement industry for over 25 years. Starting as a machine operator in the encapsulation department back in the mid-90's he quickly fell in love with the industry and its unique approach to providing solutions for people looking for alternative therapies. As his career progressed his expertise shifted from operating machines to product development and, for the last 15 years, quality. In 2009 the 21 CFR Part 111 dietary supplement cGMPs were introduced and he saw this as an opportunity to be on the forefront of developing compliant systems. Since that time, his focus has been on helping companies navigate the regulations while coming up with realistic and budget friendly solutions. Andy has assisted many companies with FDA inspections and responses, consent decree management, and the proactive implementation of required cGMP quality systems. He is currently a consultant at Dietary Supplement Experts and oversees the cGMP compliance sector. Between Andy and Curtis Walcker (his DSE business partner who is responsible for 21 CFR Part 101 labeling compliance), they offer a complete package for dietary supplement companies looking to reduce regulatory risk.
Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. FDATrainingAlert would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.
Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.
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