Dietary and Food supplements GMP Training
Dietary Supplement GMP Compliance (U.S. Market)
This one-day training is designed to help professionals understand and implement GMP compliance requirements for dietary supplements exported to the U.S. market. It provides a comprehensive overview of U.S. Food and Drug Administration (FDA) regulations and practical strategies for compliance.
What the course covers
- 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
Who should attend?
This training is ideal for professionals working in the dietary supplement industry in these fields:
- Quality Assurance (QA)
- Production
- Quality Control (QC)
- Warehouse Operations
- Regulatory Affairs
The course can be offered virtually or on-site. Content can also be customised to best suit your needs. Ready to learn more on Dietary Supplement GMP Compliance (U.S. Market)?
Contact Us for more details on this one-day virtual training course! You can also check out our training calendar for upcoming schedule.
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