Regulatory Affairs Fundamentals
FDA Regulatory Literacy for Cross-Functional Teams
Regulation translated into business language.
Why This Training Exists
Most regulatory training is designed for regulatory affairs professionals. This workshop is designed for everyone else — the R&D scientists, marketing managers, operations leads, and supply chain coordinators who interact with FDA-regulated products every day but don't have a regulatory background. It translates the regulatory landscape into practical business context without overwhelming participants with technical detail.
Who this is for
Product development teams, marketing and brand managers, operations and supply chain staff, customer service teams, and any employee who works with FDA-regulated products but doesn't specialize in regulatory affairs. Excellent for new hire onboarding across functions.
Topics Covered
- FDA organizational structure and how it affects your business
- How FDA regulates food, dietary supplements, cosmetics, and pharmaceuticals differently
- Labeling requirements — what must appear, what's prohibited, and common violations
- Claims — structure/function, health claims, and the lines you can't cross
- Facility registration, product listing, and notification requirements
- Adverse event reporting and what triggers FDA attention
- Import/export regulatory considerations for global supply chains
- How to work effectively with your regulatory affairs team
Delivery Formats
Half-Day Workshop
Core regulatory literacy in a focused, accessible format. Designed to fit into a standard workday without pulling teams away for extended periods.
New Hire Onboarding Module
Condensed version integrated into your existing onboarding program. Ensures every new employee understands the regulatory environment they're working in from day one.
Regulatory Areas Covered
- Federal Food, Drug, and Cosmetic Act (FD&C Act) — foundational authority
- 21 CFR Part 101 — Food Labeling
- 21 CFR Part 111 — Dietary Supplement GMP and labeling
- FDA Guidance — Substantiation of Structure/Function Claims for Dietary Supplements
- Dietary Supplement Health and Education Act (DSHEA)
Build Regulatory Literacy Across Your Organization
This workshop is most effective when delivered to cross-functional groups together — creating a shared regulatory vocabulary that improves collaboration and reduces compliance risk. Contact us to schedule.