This training will provide a practical methodology for creating and applying Risk-Based Equipment Validation. It will show an example of how this process may be integrated into a facility Master Validation Plan.
Why Should You Attend:
In installing equipment, how much validation is enough? How much is too much? Risk-Based Validation establishes rules for what is appropriate and is the FDA-preferred method for determining what qualification protocols are required. It is based on the intended use of the equipment and the impact it may have on regulated processes, safety and quality.
This presentation teaches a practical methodology for creating and applying Risk-Based Equipment Validation. It shows an example of how this process may be integrated into a facility Master Validation Plan. It includes a specific real-life project involving over 100 separate pieces of equipment and utilities, and the regulatory inspector's subsequent comments.
Areas Covered in the seminar:
- Risk-Based Equipment Validation.
- Equipment and Utility Qualification.
- Risk management Tools.
- Functional Risk Analysis.
- Risk Scoring.
- Risk Mitigation.
- Score-Based Validation.
- Project Outcomes.