Two Partners. Two Practical Principles. One Powerful Approach.
The Practical Solutions Group, LLC
152 Witherspoon St.
Princeton, NJ 08542
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Drug Information Association 43rd Annual Meeting

Validation Quality and Costs: lt’s All About the Risk

Session Chair
Leonard A. Grunbaum Partner The Practical Solutions Group, LLC United States

Session Description
“Good quality is cheap; it’s poor quality that is expensive.” This 1998 quote from Money Magazine provides the premise for this session, which is that computer systems validation should be of value to the business without putting the business out of business. The key questions here are: what should be validated?; how much is enough?; and, how do I figure it all out? The answer to these questions involves an understanding of risk. This session will focus on the concept of risk, in the context of computer systems validation, to address these questions.

This session is designed for those who are responsible for validation-related aspects of pre-clinical, clinical and / or manufacturing operations. This includes those responsible for the operations themselves, validation, and quality assurance. At the end of the session, attendees should be able to identify the primary risk areas associated with computer system validation, understand the impact of these risks, and understand the differences in methods to assess and manage risk.

Hands-On Risk Analysis
Douglas Patrick Stephens
FormaliS North America

Inspection Readiness: A Challenge for Validation
Imtiaz H Mohiuddiq, PHD
Manager, Systems Validation
Otsuka Maryland Research Institute, Inc
United States

A Layered Approach to Managing Computer Validation Risks: A Case Study of Different Computer Layers and Validation Approaches
James Huang, PhD
Director, Quality Assurance & Regulatory Compliance
Almac Clinical Technologies
United States