ComplianceOnline

The New Dietary Supplements CGMPs

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

recorded version

$249.00
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
Last Recorded Date: May-2008

Training CD

$500.00
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

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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.

Description

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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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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