Why is FDA at my facility, and what do I do during an inspection? 2016

Topics

• 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?

Who should Attend

• Subject Matter Experts (SME)
• Top and Middle Management
• Compliance Management
• Quality Assurance/management
• Laboratory
• Manufacturing
• Regulatory Personnel