I have finalised the demo for the ICH-GCP E6 R3 refresher course. Overall, I liked the content and the interface. I also want to thank Whitehall Train...
About
Owning an AI System training provides practical knowledge of AI system ownership and lifecycle management in regulated life-sciences environments.
Learners explore intended use, governance, accountability, risk assessment, validation, deployment, human oversight, performance monitoring, change control and retirement.
The course covers supplier management, documentation, traceability, data integrity, privacy, security, fairness and incident management.
Practical examples demonstrate how to maintain effective controls and ensure AI systems remain fit for their intended use.
Learners also explore the relevance of GxP, data-protection requirements, recognised standards and the EU AI Act.
Upon successful completion, learners receive a certificate demonstrating their knowledge of AI system ownership and lifecycle management.
- AI System Owners, Governance, Quality, Regulatory and Compliance Professionals
- Pharmaceutical, Biotechnology, Medical Device and Life Sciences Professionals
- GxP, Validation, IT, Digital Transformation and AI Professionals
- Data, Privacy, Security, Risk Management and Project Management Professionals
What you will learn
Understand the principles of AI system ownership and lifecycle management in regulated life-sciences environments, including intended-use definition, accountability, governance responsibilities, provider and deployer roles, and regulatory expectations.
Learn how to manage AI systems from initial selection and assessment through validation, deployment, performance monitoring, change control and retirement, while considering safety, fairness, privacy, security, data integrity and human oversight.
Develop practical knowledge of AI risk assessment, lifecycle documentation, traceability, supplier management, incident handling and ongoing performance evaluation to help ensure AI systems remain fit for their intended use.
Gain an understanding of how AI lifecycle responsibilities interact with GxP requirements, data-protection obligations, recognised standards and the EU AI Act to support responsible, compliant and inspection-ready AI system management.
Course Syllabus
- A Defence You Can Evidence, Not a Human You Can Name
- The order is the order a system is actually taken on
- Melbrigg Group - case study
- Every instrument on these screens carries its status
- The artefact everything else is measured against
- Purpose, and the input sample space
- Edge cases, failure modes and bias
- Who signs it, and the date the signature has to precede
- Context of use and credibility: the medicines-side words
- Classification as a record, and purpose across the whole life
- The package a model actually needs
- Acceptance criteria before testing
- The benchmark: the process you would replace
- Test data nobody touched
- The hold-out set is spent the moment you look at it
- Evaluate the system that will actually run
- Two tests, one change, one file
- The device-law test, and a guidance written before the problem
- The AI Act test, and the route that needs writing down first
- The mature comparator, and what travels
- The United Kingdom proposal, and a sheet you can defend
- Same technique, opposite answers - and the file you hand over
- The obligation is dense. The methodology was not located.
- The obligations that do bite, and where each one sits
- Device-law surveillance, and a guidance that never says AI
- Choosing a measure, setting a level, defending the choice
- Oversight decay, the override rate, and re-qualification
- From a monitored level to a change that may proceed
- What is settled, what is draft, and what was reopened
- Guardrails, and what the measurement actually shows
- Close human supervision, and the step that records it
- The supplier file, and what you demand in writing
- The production surface: what an authority actually reads
- The assessor, the auditor, and the one published finding
- Taking ownership of a system, in the order it happens
- How you defend a level no scan of the record located
- What to do when you get back to your own system
- Course completion
- 📘 Bonus: Owning an AI System eBook (Free with purchase)







