AI is no longer a future concept in lifesciences, it’s actively being deployed across business processes from regulatory submissions to manufacturing monitoring to quality operations.
But while adoption is accelerating, governance and validation approaches are struggling to keep up. Most organizations we work with today are under-validating AI.
Traditional software validation methods were built for deterministic systems. AI is different: probabilistic, data-dependent, and constantly evolving. This creates new risks, new expectations, and a new need for pragmatic, risk-based assurance strategies.
In this webinar, we cut through the theory and focus on what matters most:
- How AI actually works in GxP workflows
- Why validation must evolve (and how CSA fits in)
- What regulators are expecting and how leading organizations are responding
- And most importantly, how to actually perform assurance on AI-enabled systems
We’ll walk through a real-world GenAI use case, showing exactly how AI governance and validation can be implemented end-to-end within CSA.
Key Takeaways
- Know exactly how to defend AI use during an inspection
- Identify where traditional validation approaches fail for AI systems
- Implement a right-sized, risk-based CSA strategy for AI-enabled systems
- Establish clear governance and ownership across teams
- Design monitoring and lifecycle control strategies for AI systems
- Walk away with a repeatable framework you can apply immediately
What Attendees Will Receive
AI Governance Readiness & Regulatory Alignment Checklist
A practical checklist that provides a structured, risk-based framework to assess governance, lifecycle controls, data integrity and trustworthiness across AI systems. It is mapped to key global standards and regulations including FDA AI Guidance, EU AI Act, ISO 42001, Annex 22, NIST, ISO 23894, ISO 27001, GDPR and others – ensuring comprehensive compliance, audit readiness and responsible deployment.
Modern Assurance Series: CSA & AI Governance Microlearning Series
This microlearning series was developed by industry experts, for industry experts, to build practical, foundational capabilities in Computer Software Assurance and modern AI compliance.
Designed for real-world application in regulated environments, these lessons focus on how to think, assess, and apply CSA principles effectively.
This program is ideal for:
- Upskilling validation teams
- Aligning cross-functional stakeholders in QA, IT, Engineering and Business
- Accelerating CSA Awareness and Adoption across your programs
Speakers:
🎤 Margaret Hindley: Sr. Director, Computer Software Assurance, Taiho Oncology, Inc.
🎤 Stephen Cook: Sr. Director – Governance & Operational Excellence, GSK
🎤 David DeLuca: Director, Strategic Consulting, Compliance Group
🎤 Sarada Ramamoorthy: Head- Strategic Consultant, Compliance Group
Meeting date: May 5, 2026, 11 AM to 12 PM ET
