21 CFR 111 GMP Dietary Supplement Laboratory

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

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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