This presentation teaches a practical methodology 2011 - Risk-Based Validation for GxP Facilities - Webinar By GlobalCompliancePanel

Overview: 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.

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.

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 Session:

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