ComplianceOnline

Implementing FDA's 21 CFR 111 for Dietary Supplements

Instructor: Dr. Ludwig Huber
Product ID: 703737
  • Duration: 75 Min

recorded version

$229.00
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Recorded Link and Ref. material will be available in My CO Section

Training CD

$399.00
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Read Frequently Asked Questions

Although FDA's Dietary Supplement Current Good Manufacturing Practice (CGMP) Final Rule 21 CFR Part 111 has been enforced since 2010, manufacturers, distributors and importers are still not completely aware of its impact. This webinar will highlight best practices for implementing 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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Refund Policy

Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange.

Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time.

If you have any concern about the content of the webinar and not satisfied please contact us at below email or by call mentioning your feedback for resolution of the matter.

We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email customercare@complianceonline.com call +1-888-717-2436 (Toll Free).

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