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Validity : 02nd May'25 to 12th May'25
21 CFR 111 GMP Dietary Supplement Laboratory
- Standard Operating Procedures
- Qualified/Validated Methods
- Product Specific Methods
- Process Controls
- Product Controls
- Setting Product Specifications
- Excursions and Deviations
- Trained Personnel
- Maintaining Records
Overview of the webinar
- 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
- These regulations are designed to ensure safety and consistency of the products
- 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
Who should attend?
- Laboratory analysts and managers
- Quality assurance scientists and managers
- Quality control scientists and managers
- Personnel involved in manufacture, testing
- Distributions of vitamins, minerals, herbal products, or other botanical product or raw material involved in the production of dietary supplements
Why should you attend?
- 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
Faculty - Dr.Gwen Wise-Blackman
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), Covance, and Salix Pharmaceuticals. Her focus has been in High-Throughput Screening, Cell-Based Assay Method Development and Validation, and Quality Assurance. Gwen has a Bachelor of Science degree in biology from M.I.T and a PhD in Pharmacology from UVa. She is a member of ASQ and AAPS.