Equipment qualification and process validation is a cumbersome activity if realistic but compliant approach is not applied. This session should help responsible personnel and teams to apply efforts in right direction to ensure regulator satisfaction at the same time help company operationalize full potential of both process and equipment/system.
Lack of adequate qualification or validation is a common FDA inspectional observation and FDA Warning Letter violation. Those involved in equipment qualification, manufacturing and process validation will benefit from a review of the relevant FDA rules, written and unwritten. Those involved in hosting FDA inspections will also benefit.
Areas Covered in the Session :
- Qualification vs. Validation vs. Verification
- Process Validation vs. Equipment Qualification
- Stages of Process Validation (practical approach in FDAs framework)
- Specifications, When to test, What to test, How much to test
- Elements of Protocols (IQ, OQ, PQ)
- Deliverables
- Role of QMS
Who Should Attend:
- Quality Assurance Departments
- Validation and Qualification Teams
- Engineering Departments
- Manufacturing Departments
- Operations Departments
- Maintenance Teams
- Every Personnel responsible for Qualification of Equipment and Validation of Processes
FDB3510
