Over the last few years, FDA inspections of Medical Device firms have increased significantly. As a result, citations from the agency have spiked. Given increasing public and political pressures on the Device industry, this trend figures to continue, placing your compliance efforts and revenues at substantial risk. This course is designed to provide you with an understanding of the concerns of FDA investigators, the methodologies used by the FDA and the tools necessary to successfully manage these inspections.
- FDA inspection process – Overview of the FDA regulations and recent regulatory enforcement trends
- Preparing for FDA audits – understanding the agency’s perspective and key priorities when conducting inspections
- How to address – and avoid – common problems that end up in 483s or Warning Letters
- FDA Inspection logistics and types of inspections – be prepared for any scenario
- Team and room preparation best practices
- How to prepare for an announced or unannounced FDA inspection
- How to respond to FDA inspection observations – what to say and what not to say