Better Testing for Better Systems with the Third Edition of GAMP's Testing GxP Systems Guide

Complimentary
Learning Level: Intermediate
Time: 1000 - 1100 ET 
Session Length: 1 hour

Testing has always been an important part of the computerized system lifecycle: it provides assurance that a system is fit for intended use prior to release to support a GxP process and provides confirmation after changes to the system that it remains so. Changes to a system are now more frequent than ever before; the old days of validate, freeze and forget are gone for good. Testing approaches have to be effective and efficient across the lifecycle to simplify the maintenance of the validated state throughout frequent changes to infrastructure, applications and intended use. This webinar explores the extensive updates to GAMP’s Testing GxP Systems in the new third edition of the Good Practice Guide. It reflects on recent technological advances, Computer Software Assurance approaches and the continued importance of critical thinking that industry can collectively adopt to achieve better testing for better systems. The webinar will free the attendees from the outdated emphasis on formal scripted testing, replacing it with the paradigm that all testing contributes towards finding defects and assuring the system is fit for intended use. It reinforces the use of different test types, and emphasizes that the right type of testing to use is whatever provides the most effective assurance.

Learning Objectives

  • Leverage, leverage, leverage: Testing by any means and in any part of the life cycle and in any environment all contributes to finding defects and confirming the system is fit for intended use so leverage any prior testing including supplier testing where suitable and available.
  • Make that paradigm shift from testing to provide audit/inspection evidence to testing to improve system and product quality. Your patients and your processes will thank you for it. Finding defects is an objective not a test failure.
  • Change is an unavoidable part of life now, so develop your test strategy and approaches and implement automated tools to streamline the verification of changes to infrastructure, applications and intended use.

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Speakers

Charlie Wakeham
Director
WakeUp To Quality
Ray Murphy
Fellow Software Quality Engineer
Boston Scientific