The Cutting Edge of Medical Technology Content, Community & Collaboration
Time: February 5, 2019 from 10am to 11:30am
Website or Map: https://www.traininng.com/web…
Event Type: webinar
Organized By: Traininng.com LLC
Latest Activity: Jan 9, 2019
21 CFR part 111 ("the DS CGMP rule") requires persons who manufacture, package, label, or hold a dietary supplement to establish and follow current good manufacturing practice-the CGMPs. This is to ensure the quality of the dietary supplement and to ensure that the dietary supplement is packaged and labeled as specified in the master manufacturing record.
This webinar will discuss basic Dietary Supplement CGMP of Part 111 and related requirements, to include:
FDA regulates dietary supplements under a different set of regulations than those covering "conventional" foods and drug products. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), Congress defined the term "dietary supplement", and requires that every supplement be labeled a dietary supplement. Beyond that, the industry was only subject to voluntary quality management systems and controls / GMPs, until the Dietary Supplements CGMPs were published as a "final rule" by the FDA, 21 CFR 111, in 2007.
Failure to follow these requirements results in products being termed "adulterated" or "misbranded" by the Agency. There is confusion in the industry as just what type of manufacturing controls and record keeping, and labeling content is required by the FDA, and this confusion continues to cause regulatory problems for many new and established companies in this industry.