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.
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.
This webinar will provide valuable assistance to all regulated companies that need to prepare for inspection of the facilities. We will discuss both laboratory instruments and critical facility systems. We will provide templates for risk assessment and validation strategy. A case study will illustrate the time lines, cost savings and benefits of a risk-based validation master 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.
This webinar will provide valuable assistance to all regulated companies that need to prepare for inspection of the facilities. We will discuss both laboratory instruments and critical facility systems. We will provide templates for risk assessment and validation strategy. A case study will illustrate the time lines, cost savings and benefits of a risk-based validation master plan.
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.
Who Will Benefit:
This webinar will provide valuable assistance to all regulated companies that need to prepare for inspection of the facilities, including companies in the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. Contract facilities providing clinical, laboratory and manufacturing services will also benefit.- End-users responsible for applications and systems
- QA managers and personnel
- Facility managers and personnel
- Senior Quality, Regulatory and Operations Management
- Regulatory Affairs staff
- Quality system auditors
Course Provider
Richard Poser(PhD),
