Why is FDA at my facility, and what do I do during an inspection is a seminar that covers topics such as:
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?
Why is FDA at my facility, and what do I do during an inspection brings together 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).