Project Management for Computer Systems Validation

This computer system validation training will highlight the principles of project management that can be applied to 21 CFR Part 11 compliance for Computer Systems Validation and show how you can use project management tenets to deliver on time and on budget, while meeting FDA regulatory compliance requirements.

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. 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 marry the two, to deliver on time and on budget while meeting regulatory compliance requirements.

Areas Covered in the Webinar:

• Basics of Project Management
• Basics of Computer Systems Validation
• Project Planning for a Computer Systems Validation Project
• Common Pitfalls and How to Avoid them
• What is FDA's most current thinking related to computers and electronic records?
• What are the inspection trends?
• What are most frequent recent citations for Part11?
• What are the most frequent deviations for computer system validation?
• How important is risk based Part11 compliance?

Who Will Benefit:

• Project Managers
• IT Management
• Business Process Owners
• Quality Managers
• Quality Engineers
• GxP
• Consultants
• Pharmaceutical Compliance Officers
• Biotech Professionals
• Medical Device Professionals
• Anyone involved with the FDA