FDA Guidance Manual on Supplement Facility Inspections, Sampling, and Imports: How Compliant Are You?

FDA Guidance Manual on Supplement Facility Inspections, Sampling, and Imports: How Compliant Are You?

March 18, 2021 – 2-4pm ET

Published: Thursday, February 25, 2021

Event date: 3/18/2021 11:00 AM - 1:00 PM Export event

According to the U.S. Food and Drug Administration (FDA), its Compliance Programs exist to provide instructions to FDA personnel for conducting activities to evaluate industry compliance with the Federal Food, Drug, and Cosmetic Act and other laws administered by FDA. On September 30, 2020, FDA released its Compliance Program Guidance Manual (CPGM) titled “Dietary Supplements – Foreign and Domestic Inspections, Sampling, and Imports.” Per FDA, the goal of this CPGM is to ensure companies consistently manufacture dietary supplements of acceptable quality and minimize consumers’ exposure to adulterated and/or misbranded dietary supplements.

The CPGM sheds light on FDA’s inspectional approaches based on FDA resources, priorities, and dietary supplement establishment operations. It identifies factors that will lead to a company’s being classified as a “firm known to manufacture high-risk dietary supplements.” It asserts that firms with high-risk dietary supplements include, but are not limited to, firms manufacturing botanical supplements.

The CPGM also specifies what type of inspection should be conducted based on the reason for the inspection itself (e.g., full scope manufacturing inspection, limited focus manufacturing inspection). It also includes what items or areas FDA should emphasize while onsite at your facility.

Attend the webinar on March 18 to hear perspectives on the CPGM from an industry veteran and an FDA investigator. Aaron Secrist will speak from the vantage point of industry, and Justin Boyd will provide insight from FDA’s point of view.

Answers to your questions

Submit questions BEFORE the webinar so presenters can address YOUR ISSUES during their presentation. A Q&A session will follow the speaker presentations to answer specific questions submitted in advance.

Presenters

  • Justin Boyd, Investigator, Office of Regulatory Affairs (ORA), Food and Drug Administration (FDA) – since 2008
  • Aaron Secrist, Executive Vice President of Quality, Regulatory Affairs & Operations, NOW Health Group, Inc.

Materials/Handouts

  • Presenter slides
  • Presenter biographies

Cost

  • Members: $199
  • Non-Members: $399
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