FDA Insights for AI Compliance in Life Sciences

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About This Event

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.

What You'll Learn:

FDA's Perspective on AI Governance

Danielle will share the FDA's approach to five critical pillars of AI implementation:

  • Data Quality and Management: Understanding data integrity requirements for AI systems
  • Human Oversight: The role of human supervision in AI-assisted decision-making
  • Transparency: Explainability and documentation expectations for AI algorithms
  • Ongoing Monitoring: Post-deployment surveillance and performance tracking requirements
  • Governance: Establishing robust AI governance frameworks that align with regulatory expectations, including Good Machine Learning Practices (GMLP)

MasterControl's Embedded AI Approach

Renee will share how MasterControl has designed AI foundationally with compliance built in:

  • How MasterControl's AI approach addresses each of the five critical pillars
  • Pre-built compliance controls and safeguards embedded in the platform
  • Behind-the-scenes architecture that ensures data quality, traceability, and auditability
  • What MasterControl manages versus what requires customer action

Your Compliance Roadmap

  • Documentation requirements for AI system validation and use
  • Implementing human-in-the-loop processes effectively
  • Establishing change controls for AI systems
  • Ongoing monitoring and performance evaluation protocols
  • Building internal governance structures for AI adoption

Danielle Dorfman Faruq

Digital Health and AI/ML Policy Specialist

FDA

Danielle Faruq is a Digital Health Specialist at the FDA's Digital Health Center of Excellence. She began her career as a biomedical engineer and technical reviewer for cardiovascular and neurological devices at FDA. Danielle has held various roles in regulatory affairs and quality systems at start-ups like WellDoc and Kintsugi Health. At Apple Inc., she led the submission of Apple's first FDA-cleared medical software on the Apple Watch and worked as a Health Studies Scientist, spearheading large-scale data collection for AI health features on the Apple Watch and iPhone. She has been back at FDA for just over 2 years, leading AI and digital health policy initiatives.

Renee VonBergen

Senior Product Manager

MasterControl

Renee VonBergen is an Artificial Intelligence (AI) product specialist focused on AI strategy, and the ethical and safe use of AI in life sciences. She has worked on several commercial products for Apple and other companies that leveraged natural language processing and predictive analytics. She joined MasterControl’s AI team in 2023.

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