FSMA’s preventive controls rule, 21 CFR 117.5(e), exempts finished dietary supplements (DS) from the requirements for preventive controls and a supply-chain program if they are in compliance with 21 CFR 111, and with adverse event reporting. Exemption from these two elements of Part 117 does not mean dietary supplement manufacturers are unaffected by FSMA.
EAS one-day seminar, FSMA Part 117 Compliance for Dietary Supplements will cover the elements of FSMA with specific applicability to the dietary supplement industry, with information geared to the various roles within a food manufacturing facility. Attendees will leave with a clear understanding of their role and how to better manage the implementation of the new part 117 preventive control regulations.
- An Introduction to FSMA & Part 117 Elements
- Subpart A – General Provisions
- Subpart B – Good Manufacturing Practice
- Subpart C – Hazard Analysis and Risk-Based Preventive Controls (HARPC)
- Subpart D – Modified Requirements – Warehouses
- Subpart F – Recordkeeping Requirements
- Subpart G – Supply Chain Program