READY-TO-STREAM COURSE

The First FDA Warning Letter on AI

What It Means for Your Quality System

Designed for professionals managing digital quality systems, AI-enabled workflows, computerized processes, compliance oversight, or operational decisions influenced by automated technologies.

ABOUT THE COURSE

Organizations introducing AI into quality operations must now evaluate how validation, oversight, accountability, and risk decisions withstand evolving FDA inspection expectations. This session structures practical governance approaches for AI-enabled quality systems, connecting validation controls, risk management, oversight responsibilities, and operational inspection readiness.

The session begins with the regulatory significance of FDA’s first AI-related Warning Letter and the operational signals it sends to regulated organizations. It then moves into practical quality system integration, covering validation, governance, risk management, supplier oversight, documentation expectations, and inspection-focused controls for AI-assisted activities within GMP environments.

Key Areas Covered

Managing AI governance within GMP quality system operations
CSV and validation considerations for AI-enabled applications
Data integrity and audit trail expectations for AI systems
Controlling model drift, bias, and automated decision risks
Human oversight responsibilities in AI-assisted quality decisions
Supplier qualification and third-party AI vendor oversight
Inspection readiness documentation for AI-enabled workflows

Course Director

Dr. Ginette Collazo

Dr. Ginette Collazo brings two decades of experience in human reliability, quality systems, and regulated manufacturing environments, with specialized expertise in investigation methodologies, human error reduction, and CAPA effectiveness. Her work helping organizations strengthen operational decision-making and quality oversight provides direct relevance to evaluating how AI technologies affect accountability, risk control, and inspection readiness within GMP systems.

What Happens After You Reserve Your Seat

Your registration is managed by our events team to ensure a coordinated and seamless experience.

A confirmation email outlines onboarding details and next steps
Access credentials are shared in advance so you are prepared before the session
Handouts (where applicable) are provided ahead of time
The training is delivered live via Webex with interactive participation and Q&A
Certificates of completion are issued following the session
For live + recording access, post-session availability is provided through TalkFDA
Event support remains available for any access or logistics assistance

Access is provided in a structured and professionally supported format.

A confirmation email outlines onboarding and next steps
The complete session recording is delivered through TalkFDA
Access is granted shortly after purchase so you can begin without delay
Recording includes the full presentation and instructor-led discussion
Certificates of completion are issued upon course completion
Support remains available for any technical or access assistance

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FDB1305

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