AI in Life Sciences Is Moving Fast. Learn How to Keep Up — Compliantly.

Artificial intelligence (AI) is no longer a future-state conversation in life sciences. It's showing up in quality management systems (QMS), regulatory submissions, and manufacturing operations right now. And if you're a manufacturing or quality professional, you're probably feeling the pull in two directions at once: the pressure to modernize, and the very real concern about what AI adoption means for your U.S. Food and Drug Administration (FDA) compliance obligations.

That tension is valid — and it's exactly why we created this webinar.

On June 3, 2026, join us for "Navigating AI Compliance in Life Sciences: FDA Policy Insights for AI Governance," featuring a rare, candid conversation between an FDA policy specialist and MasterControl's own AI and data leader. Together, they'll bridge regulatory guidance with practical, real-world strategies you can actually use.

Save your seat for the June 3 webinar →

The Stakes Have Never Been Higher for AI in Life Sciences

There's no longer any doubt: AI-enabled technologies are already reshaping how life science companies manage quality and navigate regulatory processes. The question is no longer whether to adopt AI — it's how to do it in a way that holds up under FDA scrutiny.

And that's where things get complicated. Most organizations are wrestling with questions like:

• What does the FDA actually expect from AI systems operating in a GxP environment?
• What does "validation" mean for a system that learns and evolves over time?
• Who's accountable when an AI-assisted decision factors into a quality outcome?
• How do you document and explain AI-driven processes to an auditor?

FDA regulation around artificial intelligence is actively evolving, and staying current isn't just a best practice — it's a compliance necessity. If you're responsible for quality, regulatory affairs, or digital transformation at your organization, this webinar isn't just interesting. It's essential.

Straight From the Source: What FDA Expects From AI in Your Operations

Here's what makes this webinar different from anything else on your calendar: you're getting insight directly from the FDA.

Danielle Dorfman Faruq, Digital Health and AI/ML Policy Specialist at the FDA's Digital Health Center of Excellence, will walk through the FDA's perspective on five critical pillars of AI implementation. This isn't a secondhand interpretation of guidance documents — it's the real thing, from someone working at the intersection of digital health policy and AI every day.

Here's a preview of some of the big topics Danielle Dorfman Faruq will cover:

1. Data Quality and Management — What data integrity truly means when AI systems are in the mix, and what regulators expect you to get right.
2. Human Oversight — How human supervision needs to be structured in AI-assisted decision-making, and why the FDA considers this non-negotiable.
3. Transparency — What explainability and documentation expectations look like for AI algorithms in regulated environments.
4. Ongoing Monitoring — Post-deployment surveillance and performance tracking requirements that keep AI systems compliant over time.
5. Governance — How to build robust AI governance frameworks that align with regulatory expectations, including Good Machine Learning Practices (GMLP).

Direct access to an FDA policy specialist is rare. This is your chance to hear how the agency is thinking about AI compliance — unfiltered, and straight from the source.

Register now to secure your spot →

Compliance Isn't an Add-On at MasterControl — It's the Foundation

Understanding what the FDA expects is only half of the equation. The other half is knowing how to build it into your operations — and that's where Renee VonBergen, MasterControl's Vice President of Data and AI, comes in.

VonBergen will share how MasterControl has approached AI from day one: with compliance designed in, not layered on top. That distinction matters tremendously in regulated environments.

Here's a taste of what she'll cover:

• How MasterControl's AI approach is architected to address each of the FDA's five critical pillars.
• The pre-built compliance controls and safeguards already embedded in the platform.
• How data quality, traceability, and auditability are handled at the architectural level — so you're not rebuilding from scratch.
• A transparent breakdown of what MasterControl manages versus what requires action on your end.

This isn't a product demo. It's an honest, practical look at what responsible AI design looks like in a life sciences context — and what it means for your path to AI compliance.

Don't miss this conversation — Register for June 3 →

Your Practical AI Compliance Roadmap — Built in 60 Minutes

Whether you're just starting to explore AI in your quality systems or you're already deep into implementation, you'll leave this webinar with something concrete to act on.

Here's what attendees can expect to walk away with:

• Clarity on validation documentation — A clear picture of what's required for AI system validation and use in a GxP environment.
• Human-in-the-loop frameworks — Practical guidance on implementing human oversight processes that satisfy FDA regulation.
• Change control strategies — How to establish and manage change controls specifically designed for AI systems.
• Monitoring protocols — Approaches to ongoing performance evaluation that meet post-deployment surveillance requirements.
• Governance building blocks — A starting point for building internal AI governance structures that align with agency expectations.

In 60 minutes, you'll move from uncertainty to clarity — and leave with a roadmap you can bring back to your team.

This Webinar Is For You If…

This webinar is built for life science professionals navigating the intersection of AI and FDA compliance. You'll want to be in the room if you are:

• A decision-maker interested in implementing AI in your life sciences organization.
• A quality assurance or quality management professional.
• A regulatory affairs specialist.
• A digital transformation or IT leader in life sciences.
• Responsible for AI governance, system validation, or implementation at your organization.

Whether you're at the beginning of your AI adoption journey or actively scaling AI-enabled solutions, this session is designed to meet you where you are.

Don't Miss It — Register for the June 3 Webinar

AI adoption in life sciences is accelerating. The regulatory expectations around it are evolving. And the window to get ahead of it — compliantly — is now.

Join us on June 3, 2026 for "Navigating AI Compliance in Life Sciences: FDA Policy Insights for AI Governance" and walk away with the regulatory knowledge and practical strategies to move forward with confidence.

Register Now — It's Free →

Can't make it live? Register anyway to receive on-demand access after the broadcast.