Implementing FDA's 21 CFR 111 for Dietary Supplements

Why Should You Attend:

In 2007, the FDA issued the Dietary Supplement Current Good Manufacturing Practice (CGMP) Final Rule 21 CFR Part 111. Its enforcement commenced in 2010. The rule requires that proper controls be in place for dietary supplements during manufacturing, quality control, packaging, labeling, and holding and distribution. This has a high impact on manufacturers, distributors and importers of dietary supplemental products.

However, manufacturers are still uncertain about how to interpret the rule, while the FDA is preparing 483 observations and warning letters. This webinar will give attendees a good understanding of requirements for 21 CFR Part 111 and provide strategies and best practice tools for cost-effective implementation.

Hand-outs:

For easy implementation, attendees will receive:

• Checklist: Implementing 21 CFR Part 111
• SOP: Internal Auditing for 21 CFR Part 111 Compliance

Areas Covered in the Webinar:

• History, current status, and future of the rule
• Requirements overview
• Examples of typical FDA warning letters
• Going through subparts: personnel, facility, equipment, production and process control, quality control, raw material, laboratory operations, manufacturing controls, packaging and labeling, records and record keeping
• The key steps towards ensuring the quality of dietary supplements
• Comparison with drug and general food GMPs
• Procedures for identity and strength/potency tests
• Practical recommendations for implementation
• Conducting internal Part 111 audits in preparation for FDA inspections
• Recommendations to avoid FDA inspectional observations and warning letters
• Most frequently asked questions and answers

Who Will Benefit:

• Manufacturers of food products
• Manufacturers of dietary supplements
• Contract manufacturers and laboratories
• QA managers and personnel
• QC and lab managers
• Regulatory affairs personnel
• Training departments
• Documentation department
• Consultants

Instructor Profile:

Ludwig Huber, Ph.D., is the director of Labcompliance and editor of www.labcompliance.com, the global online resource for validation and compliance. He has authored the books ‘Validation and Qualification in Analytical Laboratories’ and ‘Validation of Computerized Analytical and Networked Systems’. He has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11, 21CFR Part 111, and validation around the world. This includes seminars, workshops and presentations for the US FDA, China SFDA, Korea MFDS, Singapore HSA, ISPE, Japan PDA, PIC/S and several other national healthcare agencies.

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