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