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IVT’s 12th Annual Computer and Software Validation

Robust Application for Dynamic, Risk-Based CSV Processes

April 26-28, 2011
  • Philadelphia, Pennsylvania

IVT’s 12th annual event showcases the validation process for computer systems and software. Computer and software validation (CSV) has remained a FDA hot button over the last decade in the GXP environment (manufacturing, laboratory and clinical). The pharmaceutical industry has been awaiting the rewrite of CFR Part 11 for several years and while it seemed that the release was imminent, the rewrite still has not reached the public. Today, new approaches, such as EU’s Annex 11, FDA’s new process validation guidance and ASTM 2500, have taken the forefront in assisting organizations with CSV compliance. In this ‘create-your-own conference’ format, participants build their own event to suit their specific validation needs. Whether working in traditional pharmaceuticals, emerging biotechnology or the medical device industry, participants take away cutting edge information that can be immediately implemented.

Key Topics to Be Addressed:

  • A risk-based lifecycle approach to CSV

  • Network qualification planning

  • FDA inspections of computer systems

  • CSV user requirements

  • Write quality test scripts

  • Change control and configuration management

  • Software development, testing and validation

  • Use excel spreadsheets in a regulated environment

  • Conduct a gap analysis of your CSV programs

  • Ensure internet applications are compliant

For more information or to register, please contact the Center for Business Intelligence toll free by phone at 1-800-817-8601 or via e-mail at cbireg@cbinet.com.