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Computerized System Validation: Basic Concepts

Controlled and Successful CSV

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Duration: 90 Minutes
$150.00 Recorded Session
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$389.00 Training CD
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The comprehensive testing and control of computerized systems if first and foremost a matter of business continuity. The industry is absolutely dependent upon the reliability and accuracy of these systems for daily operations. Short of fire or catastrophic natural disasters, nothing is more disruptive to business continuity than the dreaded phrase, "the system is down".
A well designed validation project will provide assurance of business continuity, and consequently provide assurance of regulatory compliance. This presentation will diminish the mystery associated with computerized system validation, provide attendees with a clear understanding of the basic concepts of validation, and describe the steps to be taken by a project team leading to a well controlled and successful computerized system validation.

The basic concepts of computerized system validation originated in the 1960s, with the Department of Defense and NASA. Validation of systems became a growing issue within the pharmaceutical industry during the late 1980s and early 1990s, as the use computerized technologies became commonplace in the research and manufacturing of drug products. The FDA issued a series of regulations and guidelines to define regulatory expectations for computerized system validation. In today’s pharmaceutical 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.

Objectives of the Presentation:
  • Introduction, Historical Perspective, and Definitions
  • Computerized System Validation Master Plan
  • Validation Plan
  • Developer Assessment
  • Requirements, Design, and Configuration Specifications
  • Validation Testing
  • Procedures/Archival/Traceability
  • Validation Summary Report
  • Commissioning Memo
  • System Decommissioning/Retirement
  • Questions & Answers
Who can Benefit:
  • Project/Strategic Management
  • Quality Assurance Staff
  • IT Staff
  • Operations Staff
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