Computer System Validation: Step-by-Step

Training Options


Overview:

This webinar details all of the templates used to create validation documentation, usually saving two-thirds of the time and costs. The 10-step risk-based approach to COTS software validation minimized documentation and ensures efficient implementation of new and upgraded computer systems. This experience will prepare you to perform a validation project.

Areas Covered in the Session:
  • Learn which documents the FDA expects to audit.
  • How to use the risk-based validation approach to lower costs.
  • How to link requirements, specifications, risk management, and testing.
  • Document a computer system validation project using easy to understand fill-in-the-blank templates.
  • Based on: "Risk-Based Software Validation – Ten Easy Steps" (Davis Horwood International and PDA - www.pda.org, 2006).
  • Step-by-step instructions for performing and documenting a risk assessment, and how to use the results to reduce validation documentation.
  • Reduce testing by writing test cases that trace to elements of risk management.
Who Will Benefit:
  • IT
  • QA
  • QC
  • Laboratory staff
  • Managers
  • GMP, GCP, GLP professionals
David Nettleton, is an FDA Compliance Specialist for 21 CFR Part 11, HIPAA, and Computer System Validation. His latest book is "Risk Based Software Validation - Ten easy Steps" that relates to the development, purchase, installation, operation and maintenance of computerized systems used in regulated applications. He specializes in performing gap analysis, remediation plans, SOP development, vendor audits, training, and project management. He has completed more than 185 mission critical software validation projects.


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