2-day In-person Seminar: Why is FDA at my facility, and what do I do during an inspection? 2013

Key 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).