Risk-Based Equipment Validation

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

Instructor Profile:
Rich Poser, 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.

Dr. Poser was Director of Analytical Sciences and later Director of Information Systems at the Fisons Pharmaceuticals site in Rochester, NY. Following work in product development, laboratory automation, and validation and quality systems for the Mylan Pharmaceutical Company, Rich joined Dura Pharmaceuticals in San Diego as Analytical Laboratory Director and Director of R&D Quality Assurance. After the acquisition of Dura by Élan, 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, cGMP Regulations and analytical methods validation, and has presented or chaired public seminars on cGMP Requirements, Computer System Validation, Vendor Qualification Auditing, Analytical Methods Validation and Infrastructure Qualification.

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