SQA Webinar: The Future of Quality Software Validation: CSA, AI, and the Need for Critical Thinking
This online webinar will be given via Zoom.
Presented by: Karin Ashkenazi, ZenQMS
Webinar Category: Regulatory
Regulatory Area of Interest: IT Compliance/CSV/CSA
Description:
The FDA’s Computer Software Assurance (CSA) guidance and the EU’s updated Annex 11 asked quality professionals to think differently: focus on what matters most, take a risk-based approach, and use real critical thinking instead of endless documentation.
But technology is changing fast and AI is emerging in software systems across the life sciences spectrum. These advances bring exciting opportunities but also new challenges for validation. How should Quality leaders apply CSA principles to AI-powered systems to stay compliant without slowing innovation? How can we assure regulators – and ourselves – that AI-driven outcomes are consistent, reliable, and controlled? What does “validated” even mean when the software never truly stops evolving?
In this session, attendees will walk away with an understanding of:
- What CSA validation looks like in practice
- The level of validation support Quality teams should expect from vendors
- How the CSA and Annex 11 approaches can be applied to validate AI-powered software
- How Quality teams can strengthen their validation strategies for the next generation of technology
Attendees will walk away with a clear understanding of how to balance innovation and compliance using modern, risk-based validation practices that keep pace with regulatory expectations and rapid technological change.
RQAP Re-registration units approved: TBD