Dietary Supplements CGMPS - 21 CFR 111 Compliance
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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:
Why should you Attend:
- Quality Management System / QA / QC
- Personnel, Facilities, Equipment
- Software controls
- Production and Process Controls
- Holding and Distribution
- Complaints and Returns
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
Areas Covered in the Session:
Who Will Benefit:
- History of Dietary Supplement regulation in the U.S
- The Dietary Supplement Health and Education Act (DSHEA)
- The key requirements of the Dietary Supplements CGMPs, 21 CFR 111
- Required steps for CGMP compliance
- Problem areas, common pitfalls
- Implementation: Systems, templates and tools
- Senior Management in Dietary Supplements Industry
- Others Tasked with Product, Process, Validations, CGMP Responsibilities
- Interested Consumer Groups
- Medical and Other Healthcare Professionals, Staff and Office Personnel
John E. Lincoln is a medical device and regulatory affairs consultant. He has helped companies to implement or modify their GMP systems and procedures, product risk management, U.S. FDA responses. In addition, he has successfully designed, written and run all types of process, equipment and software qualifications/validations, which have passed FDA audit or submission scrutiny, and described in peer-reviewed technical articles, and workshops, world wide.
John has also managed pilot production, regulatory affairs, product development/design control, 510(k) submissions, risk management per ISO 14971, and projects; with over 28 years of experience in the FDA-regulated medical products industry - working with start-ups to Fortune 100 companies, including Abbott Laboratories, Hospira, Tyco/Mallinckrodt. He is a graduate of UCLA.