Validating Cloud and Hybrid GxP Systems
- Webinar
Validating Cloud and Hybrid GxP Systems
Supplier Assessment, Change Control, and Vendor-Deployed AI
- October 14, 11AM - 12:15 PM EST
Validating Cloud and Hybrid GxP Systems
Supplier Assessment, Change Control, and Vendor-Deployed AI
October 14, 11AM – 12:15 PM EST
Most GxP environments are now hybrid whether anyone planned it or not. Legacy on-premise systems sit alongside SaaS platforms that update on the vendor’s schedule, not yours, and the validation package written at implementation assumed a system that would hold still. It hasn’t. Meanwhile suppliers are shipping AI features into validated systems as routine releases, and most quality organizations have no mechanism to catch it, assess it, or document a decision about it. This session covers how to validate systems you do not control: what to demand from supplier assessment and how far you can lean on vendor testing under CSA, how to build change control that survives a quarterly release cadence, and what to do when a feature you did not ask for lands inside a validated application.
What You'll Gain:
- Understand where supplier qualification ends and your validation obligation begins in a shared responsibility model
- Learn how to leverage supplier testing evidence under a risk-based CSA approach, and where regulators expect you to test anyway
- See how to design change control and periodic review around vendor release cycles rather than against them
- Discover how to assess and document vendor-deployed AI features introduced into validated systems
- Gain insight into what GAMP 5 Second Edition asks for in cloud and hybrid environments, applied rather than summarized
- Hear how organizations are handling this in practice, including what has failed
Who Should Attend:
- CSV, CSA, and computerized systems validation professionals
- Quality assurance and IT compliance leads
- System owners and business process owners for cloud-based GxP applications
- Supplier qualification and vendor management professionals
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October 14,
11AM - 12:15 PM EST
- CSV & CSA University Download Agenda



