This 90-minute webinar will provide a clear understanding of the concepts of computerized system validation, and describe the steps to be taken by a project team for a well-controlled and successful computerized system validation.
Why Should You Attend:
The FDA has issued a series of regulations and guidelines to define regulatory expectations for computerized system validation. In today’s medical environment, virtually all aspects of research and manufacturing are conducted using computerized systems, yet the planning, conduct, and necessary controls for validation of these systems remains problematic for many companies and industry professionals.
This 90-minute training will diminish the mystery associated with computerized system validation, provide attendees with a clear understanding of the concepts of system validation, and describe the steps to be taken by a project team leading to a well-controlled and successful computerized system validation.
Areas Covered in this Webinar:
- Introduction, Historical Perspective, and Definitions.
- Computerized System Validation Master Plan.
- Validation Plan.
- Developer Assessment.
- Requirements, Design, and Configuration Specifications.
- Validation Testing.
- Validation Summary Report
- Commissioning Memo
- System Decommissioning/Retirement
- Questions & Answers
Who Will Benefit:
- Project/Strategic Management
- Quality Assurance staff
- IT staff
- Operations staff
- Regulatory Professionals
- System Administrators
- Validation Professionals
Added by complianceonlinecom on November 5, 2012