Navigating AI Compliance in Life Sciences: FDA Policy Insights for AI Governance

Webinar Date: December 10, 2026
Time: 11:00 AM EST
Duration: 1 Hour
  • <<
  • >>

Join us for a conversation on artificial intelligence in life sciences, featuring Danielle Dorfman Faruq, Digital Health and AI/ML Policy Specialist at the FDA's Digital Health Center of Excellence, and Renee VonBergen, Vice President of Data and AI at MasterControl.

As AI-enabled technologies rapidly transform quality management and regulatory processes, life science organizations face critical questions about implementing these tools while maintaining FDA compliance. This webinar bridges regulatory guidance with practical application, giving quality professionals the insights they need to confidently adopt AI in their operations.

In this webinar you'll learn:

  • Understand the FDA's approach to five critical pillars of AI implementation — Learn the FDA's perspective on data quality, human oversight, transparency, ongoing monitoring, and governance frameworks (including GMLP).
  • See how MasterControl embeds compliance into AI by design — Get a behind-the-scenes look at the architecture, controls, and safeguards built into the platform — and what's managed for you versus what requires customer action.
  • Walk away with a practical compliance roadmap — Gain actionable steps for AI system validation documentation, human-in-the-loop processes, change controls, monitoring protocols, and internal governance structures for AI adoption.

Who should attend:

  • Quality and compliance directors
  • Regulatory affairs directors
  • Manufacturing and production directors
  • Operations directors

Register Now

  • Please complete the following information to register for this webinar. If you already have an account, and the information will be filled out for you.
  • Please enter your mailing address.

  • The webinar sponsors and American Pharmaceutical Review may use the information you have provided to contact you about this webinar and other related topics. For more information please refer to our privacy policy.
Digital Health and AI/ML Policy Specialist
FDA
Vice President of Data and AI
MasterControl
Image Mike Auerbach
Editor-in-Chief
American Pharmaceutical Review