21 CFR 111 GMP Dietary Supplement Laboratory

Duration: 60 Minutes
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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 designed to insure safety and consistency of the products. This webinar will address multiple subparts of 21 CFR 111 specifically discussing laboratory facilities, equipment/instrumentation and process controls.
21 CFR 111 GMP Dietary Supplement Laboratory
Product ID: 506484
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.

Objectives of the Presentation
  • 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
Why Should you Attend
Attendees will receive knowledge on important and essential requirements and procedures necessary for key elements of production and testing of dietary supplements.

Areas Covered
  • 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, laboratory managers, quality assurance scientists and managers, quality control scientists and managers, 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.

Topic Background
Dietary supplements must meet regulatory expectations. These requirements govern how dietary supplements are manufactured and tested. Production and testing by trained personnel must follow process and product controls established by the manufacturer. Records of all manufacturing and testing must be maintained in a quality-controlled environment to insure the quality of the product meets specifications prior to release for distribution.
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Instructor Profile:
Gwendolyn Wise-Blackman is a successful scientist/manager with increasing accountability for scientific expertise and budget in the pharmaceutical industry, including managing multiple projects. She has working knowledge of FDA/ICH GLP and GMP guidelines and has proven experience with cell-based potency assays, Cell-based neutralization assays, PK and immunogenicity ELISA used to support bioprocess techniques for large molecule therapeutics. Ms. Wise-Blackman also holds Research & Development expertise in High Throughput Screening, 7-transmembrane receptor binding assays, cell-based assays, cell culture, and ELISA. Ms. Wise-Blackman is gifted with excellent presentation skills as evidenced by numerous scientific speaking engagements and working knowledge of PMP principles. She was an invited lecturer for IBC and IVT conferences, 1999-2008.
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