Navigating AI Compliance in Life Sciences: FDA Guidance for AI Governance

In life sciences manufacturing, AI is already on the shop floor, in the quality system, and on regulators' radar. The question is no longer whether to adopt it, but how to do so compliantly and defensibly for the long haul. Drawing on insights from a policy specialist at the FDA Digital Health Center of Excellence and a MasterControl AI leader, this brief delivers a rare dual perspective on what regulators expect and what responsible AI governance looks like in practice. If your teams are moving faster on AI than your policies, this is where that gap gets addressed.

What you'll learn:

• Key FDA governance themes for AI and what they mean for your quality and manufacturing systems
• How to build a defensible AI foundation anchored to international standards, with humans meaningfully in control across the lifecycle
• Where to start with low-risk, high-value AI use cases that build confidence and compliance muscle before scaling