Free Download: KenX Dublin - Harness the Power of AI in GxP Slides

On November 19–20, 2025, ERA Sciences joined the KenX for their Harness the Power of AI in GxP event in Dublin, featuring two live presentations on model explainability, validation frameworks, and real-world results from clinical AI deployments.

The room was full of quality, clinical, and IT leaders asking one question in different ways:
"How do we bring AI into regulated systems responsibly?"

Now, you can download the slides and explore the frameworks, strategies, and case studies we shared during the event.

What’s Inside the Slides

From Black Box to Model Truth
A deep dive into explainability, model metrics, and the statistical foundations behind AI validation. Learn how to assess vendor tools, interpret performance tradeoffs, and apply context-of-use thinking in alignment with FDA draft guidance and GAMP AI principles.

Real-World Case Study: AI in Clinical Data Review
A behind-the-scenes look at how a sponsor evaluated a suite of 10 AI models inside a clinical trial platform; using risk-based validation, parallel process testing, and measurable business outcomes. From anomaly detection to model risk scoring, this is AI in action.

Who Should Download This?

These slides are built for decision-makers working at the intersection of regulatory compliance, digital innovation, and data integrity. Perfect for:

• Quality and validation leaders

• Clinical operations teams

• IT and digital transformation heads

• Anyone vetting AI-powered vendor tools in a regulated context

Takeaway

What made this session stand out wasn’t just the frameworks — it was the honest, technical conversations between people living the challenges. Attendees walked away with practical steps to:

• Evaluate black-box models

• Apply FDA’s model risk thinking

• Validate “human + AI” teams instead of AI alone

• Keep ALCOA++ principles at the center of automation

Want the Slides?

Fill out the form below to download a copy of the KenX Dublin: Harness the Power of AI in GxP presentation slides and start applying these insights to your own AI strategy.