EQUIPMENT QUALIFICATION AND PROCESS VALIDATION

🎤 Saurabh Joshi | 📅 April 05, 2024 | 🕒 10 AM Eastern Time US

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