This presentation will provide auditors who are not knowledgeable about computer system validation with a basic understanding of the requirements and expectations for validation documentation. We will address the basic components of computer system validation, the importance of assessing the quality of such validations performed by vendors, suggested procedures for reviewing validation documentation to ensure a meaningful review in a limited period of time, and how to establish reasonable remedial actions in the case of inadequate validation documentation.
Auditing CSV materials is an important element in most audits of CROs, technical service providers (TSPs), and application hosting organizations.
Attendees should have some familiarity with performing vendor audits, as this seminar will not cover basic auditing procedures or approaches.
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:
* 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
For More Information: - http://bit.ly/aLDmtD