21 CFR 117 for the Dietary Supplement Industry
Dietary supplement manufacturers may be exempt from the preventative control’s requirements of 21 CFR 117, but they are not completely exempt from all aspects of this new regulation. In this short training, we will highlight the aspects of 21 CFR 117 that apply to dietary supplement manufacturers and raw material suppliers. You will learn what new cGMP requirements in Subpart B of 21 CFR 117 are required for dietary supplement manufacturers and are now an extension of the cGMP requirements in 21 CFR 111.
Learning Outcomes
At the end of the course, you will know and understand:
- What FSMA is
- Where to find the new regulations
- What parts of 21 CFR 117 impact dietary supplement manufacturers and raw material suppliers
- The additional GMP requirements for dietary supplements found in 21 CFR 117 subpart B
Who Should Attend
ManagementManufacturingQuality control/assurancePackagingMarketingLaboratory operationsAuditingSuppliers and distributorsRegulatory affairs
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