The Nutraceutical / Dietary Supplements CGMPs per 21 CFR 111


Instructor: John E Lincoln
Product ID: 706360
Training Level: Basic to Intermediate

  • Duration: 60 Min
This webinar will evaluate the chief areas of the Dietary Supplements FDA CGMP compliance requirements as required by in 21 CFR 111, the US Law – this and related regulations mandate a ‘total quality system’ -- from customer requirements thru development, production, to customer use/feedback. Labeling requirements will also be discussed, including those uniquely geared to nutraceuticals. The steps resulting in the present FDA regulatory requirements will be reviewed. This webinar can also be a significant part of meeting a company’s annual CGMP training requirement (if properly supplemented and documented) for a neutraceutical company.
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Why Should You Attend:

The US FDA issued a final rule (law) regarding current good manufacturing practice (CGMP) for dietary supplements in August 2007, 21 CFR 111, Dietary Supplements CGMPs. It established the minimum CGMPs necessary for activities related to manufacturing, packaging, labeling, or holding dietary supplements to ensure the quality of the dietary supplement. It is one of many actions related to dietary supplements that the FDA has taken to promote and protect the public health, when voluntary / trade association inspections failed to do so. Even with this recent law, some companies have continued to add undeclared / illegal ingredients to some dietary supplements, especially in weight loss and sexual enhancement products. What is required to be in compliance, in raw materials, in production, testing, and documentation?

Areas Covered in the Webinar:

  • Basic U.S. FDA's expectations
  • US government legal history on dietary supplements
  • The dietary supplements CGMPs, 21 CFR 111
  • Current FDA Expectations / Requirements
  • Implementation expectations / requirements
  • Key dietary supplement CGMP concerns
  • Current serious industry issues

Who Will Benefit:

  • Senior and middle management
  • QA / QC
  • RA
  • R&D
  • Formulation
  • Engineering
  • Staff and Line personnel
  • Sales and Marketing
  • Operations / Production

From Dietary Supplements / Nutraceuticals industries

Free Materials:

  • Suggested formats / content will be shown in the PPT slides.
Instructor Profile:
John E Lincoln

John E Lincoln
Principal, J E Lincoln and Associates

John E. Lincoln, is Principal of J. E. Lincoln and Associates LLC, a consulting company with over 37 years’ experience in U.S. FDA-regulated industries, 23 as an independent consultant. John has worked with companies from start-up to Fortune 100, worldwide. He specializes in quality assurance, regulatory affairs, QMS problem remediation and FDA responses, submissions, process / product / equipment including QMS and software validations, ISO 14971 product risk management and human factors files / reports, Design History Files, Technical documentation. He's held positions in Engineering, QA, QAE, RA, to the level of Director and VP (R&D). In addition, John has prior experience in military, government, electronics, and aerospace. He has published numerous articles in peer reviewed journals, written numerous chapters for books on validation, conducted workshops and webinars worldwide. John is a graduate of UCLA.

Topic Background:

The US FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods, and drug products (prescription and Over-the-Counter). This is 21 CFR 111, Dietary Supplements CGMPs.

Prior to 111’s implementation, the dietary supplements industry was under a voluntary compliance program which not every company utilized or adhered to. Now, since August 2007, it’s the law in the US.

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