Why you should attend: Many auditors are unsure how to evaluate the computer system validation (CSV) materials presented during vendor audits. The presence of numerous binders of validation documentation, or a reasonably well-written Validation Summary Report, do not necessarily demonstrate that an adequate system validation occurred. What do you look for? Why is this important?

In this webinar, we will explore what you should expect to see in the system validation materials presented for audit, and how to assess whether the validation was adequate. You do not need to be a validation expert to successfully audit validation materials!

The presentation will focus on systems utilized by vendors such as Contract Research Organizations (CROs), technical service providers (TSPs), and hosting organizations supporting the Good Clinical Practices (GCP) arena (e.g, data management, Interactive Voice/Web Response [IXR], Electronic Data Capture [EDC], Safety systems) but should be applicable to other areas as well.

Areas Covered in the Session:

• Introduction
  
• Relevant Regulations and Guidance
  
• When to review CSV materials
  
• Systems to review
  
• Validation Procedures Overview
  
• Validation Package Contents Overview
  
• Expected Validation Practices
  
• Methods for Reviewing CSV Materials During an Audit
  
• Study-Specific Application Testing
  
• Corrective Measures

Who Will Benefit:

• Quality Assurance Auditors
  
• Quality Assurance Managers
  
• Clinical Program Managers
  
• Vendor Management personnel
  
• Project Managers
  
• Anyone involved in TSP audits