21 CFR 111 GMP Dietary Supplement Laboratory
Duration : 60 Minutes
Gwendolyn 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 De Read more
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
Course 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
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
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.
Course Outline:
• Standard Operating Procedures
• Qualified/Validated Methods
• Product Specific Methods
• Process Controls
• Product Controls
• Setting Product Specifications
• Excursions and Deviations
• Trained Personnel
• Maintaining Records
What You Get:
• Training Reference Materials
• Live Q&A with our Expert
• Participation Certificate
• Access to Signup Community (Optional)
• Reward Points
Who Will Benefit:
Laboratory analysts, laboratory managers, quality assurance scientists and managers, quality control scientists and managers, involved in
Please reach us at 1-888-844-8963 for any further assistance or if you wish to register
