Engineering: Dietary Supplements CGMPS - 21 CFR 111 Compliance
Dietary Supplements CGMPS,21 CFR 111 Compliance,Engineering,Health & care ,Health
NetZealous LLC
Summary
- Certificate of completion - Free
- Tutor is available to students
Overview
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:
- Quality Management System / QA / QC
- Personnel, Facilities, Equipment
- Software controls
- Production and Process Controls
- Holding and Distribution
- Complaints and Returns
- Records
Description
Why you should Attend:
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:
- 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
Who is this course for?
- Senior Management in Dietary Supplements Industry
- QA/RA
- R&D
- Engineering
- Marketing
- Consultants
- Others Tasked with Product, Process, Validations, CGMP Responsibilities
- Interested Consumer Groups
- Medical and Other Healthcare Professionals, Staff and Office Personnel
- Start-Ups
Questions and answers
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Certificates
Certificate of completion
Digital certificate - Included
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This course is advertised on reed.co.uk by the Course Provider, whose terms and conditions apply. Purchases are made directly from the Course Provider, and as such, content and materials are supplied by the Course Provider directly. Reed is acting as agent and not reseller in relation to this course. Reed's only responsibility is to facilitate your payment for the course. It is your responsibility to review and agree to the Course Provider's terms and conditions and satisfy yourself as to the suitability of the course you intend to purchase. Reed will not have any responsibility for the content of the course and/or associated materials.
