21 CFR 111 GMP Dietary Supplement Laboratory

Instructor: Gwen Wise Blackman
Product ID: 705288
  • Duration: 60 Min
This training program will provide an overview of 21 CFR 111 regulatory requirements which governs how dietary supplements are manufactured and tested. It will futher review the test procedures and documentation requirements to ensure regulatory compliance.

recorded version

1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section
Last Recorded Date: Jul-2017

Training CD / USB Drive

One CD/USB is for usage in one location only.
(For multiple locations contact Customer Care)
CD/USB and Ref. material will be shipped within 15 business days

Customer Care

Fax: +1-650-362-2367

Email: [email protected]

Read Frequently Asked Questions

Why Should You Attend:

Dietary supplements are governed by 21 CFR 111 in production, testing, storage, and distribution. Although dietary supplements are not pharmaceuticals they are still subject to stringent regulations. These regulations are designed to ensure safety and consistency of the products.

This webinar addresses multiple subparts of 21 CFR 111 to provide vital information on quality issues for companies manufacturing or testing dietary supplements. Specifically discussed during this webinar are: design of laboratory facilities, installation and qualification of equipment/instrumentation, and process controls. In addition, product controls, SOPs, standard methods, product specific methods, and product specifications are presented in this webinar. Trained personnel, records, and quality control are additional topics addressed to insure a broad overview with attention to several specific details related to proper manufacture, testing, storage, and shipping of dietary supplements.

Learning Objectives:

  • Overview of 21 CFR part 111/Regulatory Expectations
  • Understanding Requirements for Dietary Supplements (Differences from Pharmaceuticals)
  • Understanding Requirements for Test Procedures
  • Establishing and Maintaining Quality
  • Training Personnel
  • Requirements for Documentation
  • Confirmatory methods

Areas Covered in the Webinar:

  • Standard Operating Procedures
  • Qualified/Validated Methods
  • Product Specific Methods
  • Process Controls
  • Product Controls
  • Setting Product Specifications
  • Excursions and Deviations
  • Trained Personnel
  • Maintaining Records

Who Will Benefit:

  • Laboratory analysts and managers
  • Quality assurance scientists and managers
  • Quality control scientists and managers
  • Personnel involved in manufacture, testing, and distributions of vitamins, minerals, herbal products, or other botanical product or raw material involved in the production of dietary supplements
  • Consultants
Instructor Profile:
Gwen Wise Blackman

Gwen Wise Blackman
Manager, Salix Pharmaceuticals

Gwen Wise-Blackman has 20 years of combined experience in Cell-Based Assays and Quality Systems. She has worked at DuPont Pharmaceuticals, Catalent Pharma Solutions (formerly Magellan Laboratories and Cardinal Health), and Salix Pharmaceuticals. Her focus has been in High-Throughput Screening, Cell-Based Assay Method Development and Validation, Immunogenicity, Technology Transfer from client sites, and Quality Assurance. Dr. Wise-Blackman has a Bachelor of Science degree in biology from M.I.T and a PhD in Pharmacology from the University of Virginia. She is a member of ASQ and AAPS.

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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 [email protected] call +1-888-717-2436 (Toll Free).

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