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
- 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
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
Webinar - About the Author:
Richard Poser, PhD is President of First Quality Inc., a quality consulting firm focused on Quality Systems, Training and Validation. Their clients include biotechnology, pharmaceutical and medical device manufacturers, as well as the vendors such as contract laboratories, instrument manufacturers, contract manufacturing sites and software developers that support these highly regulated industries. Following an academic career in drug metabolism and chemotherapy, Dr. Poser was Director of Analytical Sciences and later Director of Information Systems at the Fisons Pharmaceuticals site in Rochester, NY. He joined Dura Pharmaceuticals in San Diego as Analytical Laboratory Director and Director of R&D Quality Assurance. Following acquisition of Dura by Ã‰lan, Rich was appointed Director of Quality Laboratory Operations and led their 21CFR Part 11 training and audit team. Now in private practice as a quality consultant, he also lectures at UCSD Extension in validation and has presented or chaired public seminars on cGMP Requirements, Computer System Validation, Vendor Qualification Auditing, Analytical Methods Validation and Infrastructure Qualification