U.S. Regulatory Framework for Dietary Supplements

• Overview of U.S. regulatory framework for dietary supplements
• The role of the U.S. Food and Drug Administration (FDA)
• Key regulations for 21 CFR Parts 111, 117, 121, and 1.511

cGMP for Dietary Supplement Requirements for 21 CFR Part 111

• Comprehensive look and overview of Subparts A – P
• Key compliance expectations for personnel, facilities, equipment, and production controls

Quality Control Systems – Under 21 CFR Part 111

• Quality Unit Responsibilities
• Testing protocols: component, in-process, and finished product testing
• Master and Batch Production Records

Food Safety Modernization Act (FSMA) Alignment for 21 CFR Part 117

• How the FSMA aligns with dietary supplement regulations
• Subpart A: General Provisions
• Subpart B: cGMPs
• Subpart F: Recordkeeping

Food Defense Requirements for 21 CFR Part 121

• Vulnerability assessments and mitigation strategies
• Food defense planning and training

Foreign Supplier Verification Program (FSVP) for 21 CFR Part 1.511

• Understanding importer obligations
• Understanding hazard analysis
• Evaluation and approval of foreign suppliers

Understanding Common FDA 483 Observations in Dietary Supplement Facilities

• Real-world case study examples
• Best practices to avoid common compliance issues