• Why Attend?
  • Speakers
  • Contact Us

Why Attend?

For quality and compliance leaders in pharma and medical device, AI pressure is real and it’s coming from both directions: move too fast without the right governance in place and you’re inviting non-compliance; move too slowly and you’re handing competitive ground to peers who figured it out first. Most organizations are somewhere in the middle—experimenting with AI, leaning on existing or new vendors to add it to their systems, but operating without a clear framework for what “AI-ready” actually means in a regulated environment.

This practical session cuts through the noise. Jake Walton, VP of Quality & Compliance at MasterControl, will share a candid look at how MasterControl approached AI the right way from the start—building human-in-the-loop architecture as a non-negotiable design principle, aligning every capability to 21 CFR Part 11, EU MDR, GDPR, HIPAA, and other applicable standards, and going all the way through ISO 42001 certification for Artificial Intelligence Management Systems. Jake will walk through what that audit process actually looked like, the lessons learned, and what comes next as regulatory guidance continues to evolve—including the EU AI Act and emerging FDA guidance.

You’ll leave with a clear picture of what AI readiness really requires across your life sciences organization—from data quality and governance frameworks to change control, cross-functional ownership, and auditability—and a practical set of recommendations you can start acting on now.

What you will learn:

  • Why AI readiness is an organization-wide initiative—not just a technology decision—and what that means for roles, responsibilities, and human-in-the-loop culture
  • What governance frameworks, SOPs, and change control for AI actually look like in a regulated life sciences context
  • What ISO 42001 certification involves, what the audit experience revealed, and how to plan for regulatory scrutiny from day one

Speakers

Select a speaker to learn more

Back
Jake Walton
VP of Quality, Compliance, and Privacy

Jake Walton is the Vice President of Quality, Compliance, and Privacy at a leading software company with nearly 20 years of experience across global regulatory, security, and privacy frameworks. His expertise includes FDA regulations (21 CFR Parts 11, 58, 210, 211 and 820) and ISO standards such as 9001, 27001, and 42001.

He leads enterprise-wide programs in quality, AI governance, and information security, aligning AI systems with frameworks like the EU AI Act, ISO/IEC 42001, and the OECD AI Principles. Concurrently, he oversees quality, security, privacy controls based on ISO 9001, ISO 27001, ISO 27701, FedRAMP, NIST 800-53, GDPR, and CCPA to ensure innovation is compliant, secure, and trustworthy.

Jake has led over 350 external audits from customers and authorities including the FDA, MHRA, TGA, Taiwan FDA, and the German Health Authority. A regular speaker at industry conferences, he champions ethical and compliant innovation in technology. He is passionate about helping organizations build ethical, secure, and scalable systems that align innovation with compliance.

Next speaker

Enquiry