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Best Practices in Computer System Validation

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Computer System Validation should be part of any good development and manufacturing practice. It also is required by the FDA and other regulations and quality system standards.

In this presentation, Tim Stein - an industry stalwart, author and consultant for computer systems validation - will discuss best practices for meeting requirements for computer system validation. Tim will base his presentation on his recent book, The Computer System Risk Management and Validation Life Cycle , Paton Press, 2006.

What will be covered?

Validation required to meet FDA and ISO 13485 requirements
How to validate new commercial systems with a prospective validation process
The minimum deliverables
What is required to establish a computer system validation capability

Who will benefit
This webinar will provide valuable assistance to all regulated companies that need to validate their systems, including companies in the Medical Device, Pharmaceutical, In Vitro Diagnostics, and Biologics fields. The employees who will benefit include:

Managers and executives responsible for Computer System Validation
End-users responsible for applications that need to be validated
Information Technology managers and personnel
Validation specialists
Consultants
Quality system auditors

Panelists

Tim Stein, Ph.D - CEO, Business Performance Associates, Inc
Tim is the founder and CEO of Business Performance Associates, Inc. (BPA), a consulting firm that specializes in both quality systems for biomedical companies and computer system validation. He is the author of Computer System Risk Management and Validation Life Cycle.

Shrihari L - Director for Engineering, MetricStream
Shrihari is the Director for Engineering at MetricStream, responsible for the Platform, Applications Development and QA. He has over 18 years of Enterprise software Development and Delivery experience spanning large and small companies in the US - from Agilent, NEC, HP, EDS - to Purpleyogi.

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