Wednesday 3rd April, 2013
10:00am to 11:15am
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:
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.
Livermore Common, Fremont, CA, 94539
Event Link - http://bit.ly/1194CTO
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3rd April 2013