FDA Inspections - How Investigators Typically Process the Results
Overview:
The presentation will cover important documents such as the Establishment Inspection Report, and the FDA Notice of Observations. The presentation will also cover the different steps the investigator takes after he/she finishes the inspection and writes the Establishment Inspection Report in the various programs used by the agency to track inspection reports and regulatory considerations.
Why should you attend: You should attend to inform yourself and staff on how the evidence is collected by FDA investigators and how it is reviewed by several agency departments and what actions are taken as a result of the reviews. Learn to be ahead of the process and take effective steps to minimize the impact of the inspection or take effective corrective action to rectify your compliance status with the agency.
Areas Covered in the Session:
- Law/Regulations of Inspections
- Logistics of Inspections
- Evidence Collection in an Inspection
- Sample Collections and the Processing of Samples for Regulatory Actions
- Notifications of Actions to FDA Import Operations for Import Alert Considerations
Who Will Benefit:
- Regulatory Affairs Directors/Managers/staff
- Plant Managers
- Quality Assurance/Control staff