Project Management for Computer Systems Validation Description: Per the CDRH, 20% of product recalls in the medical device industry are due to faulty software!!! Yet, these human, financial and reputation capital expensive issues, can be averted with computerized systems validation and 21 CFR 11 compliance. The Project Manager for a Validated Computerized System, has to deliver on time and on budget, but with the added risk of having to meet regulatory compliance, often causing project overruns, regulatory findings and missed times to market. This class will explain the basic tenets of project management, the basic tenets of 21 CFR 11 compliance for Computer Systems Validation and will show how to marry the two, to deliver on time and on budget while meeting regulatory compliance requirements. Project Management is defined as the planning and organization of an organization's resources in order to move a specific task, event or duty toward completion. However, Validation of Computerized Systems has a very specific set of tasks that are often mismanaged, resulting in missed deadlines, increased costs, and regulatory risk, and missed times to market for a company’s product. Objectives of the Presentation: o Basics of Project Management o Basics of Computer Systems Validation o
Project Planning for a Computer Systems Validation Project
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Common Pitfalls and How to Avoid them
Who can Benefit: o
Project Managers
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IT Management
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Business Process Owners
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Quality Managers Quality Engineers
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GxP
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Consultants
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Thursday, February 21, 2013 10:00 AM PST | 01:00 PM EST Live Session for one participant
Price: $243.00 Corporate Live Session 3 to 4 participants in single location. (For muliple location contact customer care)
Price:$486.00 Corporate Live Session 5 to 10 participants in single location. (For muliple location contact customer care)
Price:$986.00 Recorded Session Access recorded sessions only for one participant unlimited viewing for 6 months.
Price: $288.00