Dietary and Food supplements GMP Training
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 customized 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.
Our certification activities are provided by independent Certification Bodies, separately from any consulting activities. Impartiality is safeguarded by Eurofins Assurance’s relevant policies to avoid conflicts of interest.
The proposed training courses are independent of Eurofins Assurance’s audit and certification activities. Participation in and completion of a training course does not provide any advantage or guarantee of obtaining certification. The certification activities are managed by separate entities or teams in accordance with strict impartiality requirements.