Topics
- Details surrounding the management of inspections from announcement to close out meeting
- The steps necessary to prepare for an FDA inspection
- The methodology for responding to 483 and warning letters
- Responses to FAQs regarding typical inspector requests during inspections
- Common pitfalls to avoid during an inspection
- Templates for response letters
Who should Attend
Attendees from biopharmaceutical, pharmaceutical, medical device and biologics companies, including:
- Regulators
- Internal Auditors
- Compliance Officers
- Legal Departments
- QC Managers
- Validation Managers
- Facilities and Engineering Department Staff
- QA Managers
- Senior Management
- Compliance Consultants
