Project Management for Computer Systems Validation

This 2-hr session will highlight principles of project management that can be applied to 21 CFR Part 11 compliance for Computer Systems Validation and show you can use project management tenets to deliver on time and on budget, while meeting 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”. 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.

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.

Who Will Benefit:

• Project Managers
• IT Management
• Business Process Owners
• Quality Managers
• Quality Engineers
• GxP