Project Management for Computer Systems Validation

Why Should You Attend:

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”. 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.

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 2-hr training session 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 integrate the two, to deliver on time and on budget while meeting regulatory compliance requirements.

Areas Covered in the Seminar:

• Basics of Project Management.
• 21 CFR 11 Compliance for Systems Validation.
• Basics of Computer Systems Validation.
• Project Planning for a Computer Systems Validation Project.
• Common Pitfalls and How to Avoid them.
• Successfully Implementing System Validation And Avoiding FDA Warning Letters.