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
Problem-Solving
Problem-Solving

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


Agenda

Wednesday, 13 October 2021

ISPE Expert Xchange Session Chairs & Speakers

Charlie C. Wakeham
APAC GxP Compliance Manager
Waters Corporation
Chair
Lorrie L. Vuolo-Schuessler
Senior Director Computer Systems Quality and Data Integrity
Syneos Health
Chair
Khaled Moussally
Executive Vice President Clients & Regulatory Relations
Compliance Group Inc
Speaker
Ray Murphy
Principal Software Quality Engineer
Boston Scientific Ltd
Speaker
Ken Shitamoto
Senior Director, IT
Gilead Sciences Inc.
Speaker

ISPE Expert Xchange Rates

ON DEMAND ACCESS FOR 90 DAYS

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

Register

*ISPE Membership is required for these registration rates.


Group Discount Rate

Bring your team to an ISPE Expert Xchange

  • 3 - 5 participants - Save 10%
  • 6 or more participants - Save 15%

Group discount applies to Member/Nonmember rate only. To qualify, all registrant information must be submitted at the same time. Registrations that arrive later will NOT be eligible for the group discount. Cannot be combined with other offers. To register as a group, please contact ISPE by telephone, +1-813-960-2105 or by email, ask@ispe.org.


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ISPE Membership Benefits

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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
  • Member-only discounts on Guidance Documents, Conferences, and Training
  • Pharmaceutical Engineering® magazine
  • Communities of Practice access to pharma professionals in specific topics from around the world
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