ISPE Expert Xchange GAMP®: Realizing the Value in Validation with Critical Thinking and Computer Software Assurance

Learning Level: Intermediate
Session Length: 4 hours

With the publication of a CSA appendix in the ISPE GAMP® RDI Good Practice Guide: Data Integrity by Design guide, and a focus on applying critical thinking and CSA techniques throughout the entire system lifecycle and data lifecycle in the upcoming new GAMP Good Practice Guide, many regulated companies, consultants, and suppliers are asking “what does this mean in real life?”. The GAMP subject matter experts and members of the FDA Industry CSA team (FICSA) will take you through all the key activities in a validation project, demonstrating the gains available when using an optimal combination of critical thinking, computer software assurance and common sense. The highly interactive sessions will provide delegates with a practical experience of what can realistically be achieved, debunking some of the wilder claims on internet forums and blogs and replacing them with real-life approaches.

First-hand Strategic Insights & Actionable Takeaways 

  1. Using critical thinking to focus on effective and efficient actions and controls
  2. Increasing test coverage and defect detection with CSA without a corresponding increase in protocol pain
  3. Understanding that validation for intended use is here to stay – but we can do it a lot smarter
Small group Discussions
Small Group Discussions
Technical Presentation
Technical Presentations
Case Studies
Case Studies

Don’t miss out on this next-generation virtual experience – ISPE Expert Xchange!


ISPE Expert Xchange Session Chairs & Speakers

Charlie C. Wakeham
Global Head of Quality and Compliance
Khaled Moussally
Executive Vice President Clients & Regulatory Relations
Compliance Group Inc
Fellow Software Quality Engineer
Boston Scientific
Ken Shitamoto
Executive Director, IT - Quality and Compliance
Gilead Sciences

ISPE Expert Xchange Rates


Member $199
Nonmember   $249 
Academia/Emerging Economy/Government*  $120
Recent Graduate*  $75
Student* $75

Buy on Demand

*ISPE Membership is required for these rates.

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Benefits include:

  • Online access to select ISPE Good Practice Guides that will help you learn how to practically implement best practices and principles
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