Why is FDA at my Facility, and What do I do During an Inspection? 2016 is a seminar that covers topics such as:
- Step by step instructions to handle FDA 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?
- 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? 2016 brings together:
- Subject Matter Experts (SME)
- Top and Middle Management
- Compliance Management
- Quality Assurance/management
- Laboratory
- Manufacturing
- Regulatory Personnel