21 CFR Part 111 - FDA Inspections for Dietary Supplements - How to Prepare


Instructor: Andy Swenson
Product ID: 706752

  • Duration: 60 Min
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.
Last Recorded Date: Oct-2021


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Read Frequently Asked Questions

Why Should You Attend:

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:

  • What to expect during an FDA inspection.
  • What the FDA can inspect.
  • What the FDA does not authority to inspect.
  • What documents will be required.
  • How to address the FDA.
  • What expectations does the FDA have?
  • How to reduce risk during an FDA inspection.

Who Will Benefit:

  • Dietary supplement manufacturers
  • Dietary supplement brand owners
  • Executives responsible for navigating an FDA inspection
  • Employees who will participate in the FDA inspection
Instructor Profile:
Andy Swenson

Andy Swenson
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.

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