00
days
00
hours
00
minutes
00
seconds
Overview
The future of quality –
AI-driven, human-led
Explore what compliant AI adoption looks like in regulated environments and how life sciences teams can move forward while expectations continue to evolve.
✧
Why this Summit, why now: AI is transforming quality and raising new questions about transparency, accountability, and oversight. Join QA leaders, regulators, and auditors to explore compliant AI adoption in life sciences.
What to expect
Where AI adoption
meets governance
As AI enters quality workflows, how should it be governed across validation, traceability, and reliance—and where must responsibility stay human?
✧
What you’ll leave with: You’ll gain a clear view of the key questions in AI for quality today: what human-in-the-loop really means, where regulations stand, what current FDA and EU guidance for model accountability clarifies, and what is still uncertain.
What’s really at stake
AI will change how quality teams work, but not the need for evidence, ownership, or accountability. Gain clear tools and strategies to adopt AI confidently while staying compliant at all times.
Interactive panels
and keynotes
Hear directly from experts applying AI in life sciences, covering validation, inspection readiness, data integrity, and how to get reliable results in practice.
Insightful
workshops
Learn how to implement AI in quality while maintaining traceability and compliance, with practical approaches you can use immediately.
Practical oversight
frameworks
Turn “human-in-the-loop” from theory into practical oversight and build governance that aligns with FDA guidance for AI credibility and EU GMP Annex 22.
Topics in focus
What’s on the quality table
- Regulatory
- QMSR
Regulatory Evolution and AI in Quality
- Leadership
- Quality culture
Quality Culture, Leadership and the Role of QA
This topic explores how QA and quality culture work together, focusing on collaboration, business alignment, and QA’s role in decision-making and growth.
- Data safety
- Analytics
Connected Quality Systems and Data Visibility
- CAPA
- root cause
Root Cause Analysis and CAPA Effectiveness
Many organizations struggle with ineffective investigations and recurring issues. This topic focuses on stronger root cause analysis, more effective CAPAs, and building lasting problem-solving quality systems.
- risk management
- supply chain
Early Quality Involvement and Risk Anticipation
Quality is often introduced too late, leading to rework and higher risk. This topic explores how to embed quality earlier, improve risk management, and support more efficient operations.

