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
- Using critical thinking to focus on effective and efficient actions and controls
- Increasing test coverage and defect detection with CSA without a corresponding increase in protocol pain
- Understanding that validation for intended use is here to stay – but we can do it a lot smarter
Small Group Discussions
Technical Presentations
Case Studies
Problem-Solving
Don’t miss out on this next-generation virtual experience – ISPE Expert Xchange!
Agenda
- 1000 – 1005
Workshop Introduction and WelcomeChair - 1005 – 1130
Investing Effort in Validation Planning, Specification and ConfigurationChair - 1130 – 1200
ISPE Networking Coffee TalkThis face-to-face forum gives you the chance to have 1:1 conversations in small groups via video chat. Connect with attendees and engage with the speakers about their topics during this networking break.
- 1200 – 1330
Gaining Verification Improvements using CSA - 1330 – 1355
Validation Reporting EssentialsChair - 1355 – 1400
Workshop Close - 1400
ISPE Networking Coffee TalkThis face-to-face forum gives you the chance to have 1:1 conversations in small groups via video chat. Connect with attendees and engage with the speakers about their topics during this networking break.
ISPE Expert Xchange Session Chairs & Speakers
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