The New Dietary Supplements CGMPs

Instructor: John E Lincoln
Product ID: 700811
  • Duration: 60 Min

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section

Training CD

One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-963-2556


Read Frequently Asked Questions

The U.S. FDA has issued the final rule establishing regulations requiring current good manufacturing practices (CGMPs) for dietary supplements / nutraceuticals.


This requires that proper controls be in place for dietary supplements so that they are processed in a consistent manner as to identity, purity, strength, and composition, and meet quality standards.

The rule applies to all companies that manufacture, package, label, or hold such products for sale in the U.S. The rule has a staggered three-year phase-in for small businesses. It's effective June 2008 for large companies, June 2009 for companies with less than 500 employees, and companies with less than 20 employees have the full three years (June 2010) to comply with the regulations. The CGMPs will help companies in their scientific studies.

Areas Covered in the seminar:

  • The New Dietary Supplement CGMPs, 21 CFR Part 111.
  • Food-based, but … the pharma model.
  • Design/construction of facilities; maintenance; cleaning.
  • Proper manufacturing operations.
  • Quality control procedures.
  • Testing incoming, in-process materials, and final product.
  • Handling consumer complaints.
  • Maintaining records; a 'state of control'; Management Review.
  • Going from non-compliance to full compliance.

Who will benefit:

  • Management at all levels.
  • Project Leaders.
  • Regulatory affairs.
  • Quality systems personnel.
  • R&D and Engineering staff.
  • All charged with new product development, regulatory submissions, initiating / overseeing company-wide training, production, validation, and complaint handling.
  • Identified Staff, operations and line personnel who desire to assume "train-the-trainer" roles to assist compliance.

Instructor Profile:

John E. Lincoln, Consultant, has successfully developed and implemented and trained to device, pharma, medical gases, and dietary supplements CGMP-compliant systems. He has conducted compliance audits in all these areas. His systems have passed FDA audit or submission scrutiny, and have been described in peer-reviewed technical articles, and workshops, world wide. John has also managed pilot production, regulatory affairs, product development projects; with over 25 years of experience, in FDA-regulated industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco / Mallinckrodt. John serves on the Reader and Editorial Review Boards of MDDI Magazine and the Journal of cGMP Compliance, and Intermountain Biomedical Association); he publishes a newsletter. He is a graduate of UCLA.

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