Dietary Supplement Training
The FDA regulates both finished dietary supplement products and dietary ingredients. Manufacturing of these products is regulated under 21 CFR Part 111 – Current Good Manufacturing Practice (cGMP) in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements or 21 CFR Part 117 – Current Good Manufacturing Practice (cGMP), Hazard Analysis, and Risk-based Preventive Controls for Human Food. In addition, dietary supplements and dietary ingredients are subject to the Food Safety and Modernization Act (FSMA).
Training is essential for maintaining high standards of quality assurance and compliance to these regulations, and to assure the safety of the supply chain.
Our training program can be customized to meet your company’s specific needs. We can create a customized agenda from our listed topics or we can incorporate other relevant topics that you request and would be appropriate for manufacturers, packagers/ labelers, or holders of dietary supplements.
Examples of 483s, Warning Letters or other official action will be included, as appropriate.
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Dietary Supplement Topics
- GMPs for dietary supplements
- Good Documentation Practices
- Facility requirements and maintenance
- Sanitation and contamination control
- Pest control
- Equipment qualification
- Preventive maintenance
- Roles of QA/QC
- SOPs
- Warehousing and material control
- Component testing
- Out Of Specification investigations
- Batch records and material disposition
- Change control
- Supplier verification including FSVP
- HACCP assessments
- Shipping validation
- CAPA resolution
- Traceability and recalls