The Nutraceutical / Dietary Supplements CGMPs per 21 CFR 111

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Start Date: 2020-10-27
End Date: 2020-10-27
Time: 10:00 am to 11:00 am

Location: California


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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.
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
Staff and Line personnel
Sales and Marketing
Operations / Production
From Dietary Supplements / Nutraceuticals industries

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