Risk-Based Validation of cGMP Systems
This presentation will review a methodology for implementing Risk-Based Validation of test equipment, facilities and analytical instruments used in GLP, cGMP and GCP facilities.
A case study is presented for the construction qualification, relocation and new equipment installation for a cGMP facility. The cost and time savings associated with using risk-based validation will be presented. Over 3,000 systems or pieces of equipment were installed or relocated in a short time frame at a substantially reduced cost. A risk-based approach to validation was employed, dramatically reducing the cost and time for facility qualification. Comments by regulatory inspectors will be discussed.
Why should you attend:
How much validation is enough? How much is too much? When should you validate what system? Risk-based validation is the new and FDA-preferred methodology, assuring that sufficient validation is done to meet regulatory and business requirements.
Areas Covered in the Session:
- Risk-Based Validation
- Equipment and Utility Qualification
- Risk management Tools
- Functional Risk Analysis
- Risk Scoring
- Risk Mitigation
Who Will Benefit:This webinar will provide valuable assistance to all regulated companies that need to validate their systems, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields and associated vendors such as contract research, manufacturing, testing and systems. The employees who will benefit include:
- End-users responsible for applications that need to be validated
- QA managers and personnel
- Information Technology managers and personnel
- Validation specialists
- Facility staff