Search and Access Topics related to Artificial Intelligence and Digital Transformation. Let us support your digital journey! The first half of the page is dedicated to downloadable documents, while the second half gives you access to recordings of sessions with subject matter experts.
Report - Conduct a Self-Assessment for your AI readiness related to Culture, Governance & Organization, Data Management, and Tools & Techniques. Access Here —>
Poster - Assess your AI readiness across Culture, Governance & Organization, Data Management, and Tools & Techniques. Access Here —>
Poster - This poster was shared at the HFES Conference to open discussion on the work and goals of the Human Factors Center in the Pathway Collaborative Community. Access Here —>
AI Compliance Roadmap 2026: FDA, EMA, MHRA, Swiss Medic & Beyond
The AI regulatory landscape in life sciences is evolving faster than many organizations realize. If you're implementing AI in GXP environments—or planning to—there are critical developments you need to understand.
Expert: Janeen Skutnik-Wilkinson, Eli Lilly
Recording: Access the Recording and Slides
The AI revolution is here—but are you ready to validate, regulate, and leverage it with confidence? Our Expert Panel shared:
⚖️ EU AI Meets MDR: Navigate the convergence of EU AI Act, MDR, and ISO/IEC 42001. Learn to integrate compliance into your QMS while driving innovation.
📊Statistical Truth & Business Impact: Decode confusion matrices, navigate false positives vs. negatives, and apply FDA-aligned frameworks to assess black-box AI models in GxP environments.
Experts: Attrayee Chakraborty, Andy O’Connor and Priya Setty
Recording: Access the Recording and Slides
Our expert panel explored the critical intersection of compliance and innovation in process validation such as:
✅ Integrating digital tools into validation workflows
✅ Taking first steps and managing two systems - temporarily
✅ Implementing real-time process monitoring systems to improve validation assurance
Learn actionable insights into practical steps for creating robust, future-ready validation programs that ensure patient safety worldwide. Transform how your organization approaches validation in today's digital-first environment.
Expert Panel: Christine Kattappuram, Marla Phillips, Neal Schmidt
Recording: Access the Recording and Slides
Whether you are:
>Just starting to explore AI
>Wondering how AI might impact your work
>Looking to understand practical use cases
>Hoping to learn from others' experiences
This complimentary session was designed for professionals eager to understand AI's potential in Quality.
Expert: Brian Chviruk, Quality Systems Operation Leader at Takeda, walked through a specific use case, sharing lessons learned and practical insights.
Recording: Access the Recording and Slides
