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.
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
Course Content
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.
Speaker
Andy SwensonCourse Provider
Andy Swenson,
