Topics
- What to do when FDA knocks – step by step instructions to handle inspections
- Which FDA sanctions apply to you, and how to operate in compliance with FDA requirements
- What is a front room and back room? Do you need one?
- How to handle day by day inspection scenarios?
- Are your SME’s the right people, and are they ready/right for the job?
- Runners and Scribes? What do they do?
- Steps for responding to 483’s and Warning Letters
- Why responses to 483’s and Warning Letters are critical?
Who should Attend
Subject Matter Experts (SME), Top and Middle Management, Compliance Management, Quality Assurance/management, Laboratory, Manufacturing and Regulatory Personnel from Supplements (Food, Med Tech), FDA regulated Industries (Medical Device, Pharmaceuticals and Dietary).
