The First FDA Warning Letter on AI - What It Means for Your Quality System

The first FDA warning letter tied to artificial intelligence marks a turning point for GMP-regulated companies. AI already helps with automated quality reviews, predictive maintenance, complaint handling and CAPA management, and the letter makes clear that regulators want AI-supported processes validated, controlled, monitored and fully part of the quality management system (QMS).

This 60-minute webinar explains what the enforcement action means and how FDA's requirements for validation, data integrity, change control, risk management and oversight carry over to AI-driven systems and the decisions they support.

You'll also look at practical ways to bring AI into an existing quality system without losing compliance, from supplier qualification and algorithm validation to human oversight and deviation management, so you can prepare for inspections and protect patient safety and product quality.

• Explain why FDA's first AI-related warning letter matters for GMP-regulated industries
• Identify FDA expectations for AI governance in GMP environments
• Describe how AI affects quality systems, validation and data integrity requirements
• Apply risk-based approaches to AI implementation and oversight
• Meet documentation and change control requirements for AI-enabled systems
• Evaluate AI risks such as bias, cybersecurity and automated decision-making
• Plan how to integrate AI into CAPA, deviation management and quality operations
• Prepare for regulatory inspections that involve AI-driven technologies

• Overview of FDA's first AI-related warning letter
• Regulatory expectations for AI in GMP-regulated industries
• AI governance and integration with the quality system
• Computer system validation (CSV) and AI validation considerations
• Data integrity and audit trail requirements for AI systems
• Managing AI risks: bias, hallucinations and model drift
• Change control and lifecycle management for AI applications
• Human oversight and accountability in AI-assisted processes
• AI in CAPA, deviations, complaints and risk management
• Supplier qualification and oversight of third-party AI vendors
• Inspection readiness and documentation best practices
• Future trends in FDA regulation of AI

AI use in regulated industries is growing fast, yet many companies are still unsure what FDA expects for validation, oversight, documentation and risk management. The first AI-related warning letter shows that regulators are looking closely at how AI-enabled systems are implemented and controlled.

This session gives QA, regulatory, validation, compliance, IT, operations, data integrity, risk and audit professionals, and leaders weighing AI adoption, practical guidance on the risks and the steps to keep quality systems inspection-ready.

• Quality Assurance Managers and Directors
• Regulatory Affairs Professionals
• Validation and Computer System Validation (CSV) Specialists
• Compliance Officers
• Manufacturing and Operations Leaders
• IT and Digital Transformation Managers
• CAPA and Deviation Management Teams
• Data Integrity Specialists
• Risk Management Professionals
• Internal Auditors and Inspection Readiness Teams
• Executive Leadership evaluating AI adoption strategies.

Ginette Collazo, Ph.D. is an Industrial-Organizational Psychologist with 20 years of experience that specializes in Engineering Psychology and Human Reliability, disciplines that study the interaction between human behavior and productivity. She has held positions leading training and human reliability programs in the Pharmaceutical and Medical Device Manufacturing Industry.Nine years ago, Dr. Collazo established Human Error Solutions (HES), a Florida based boutique consulting firm, where she has been able to position herself as one of the few Human Error Reduction Experts in the world. HES, led by Dr. Collazo, developed a unique methodology for human error investigations, cause determination, CA-PA development and effectiveness that has been implemented and proven amongst different industries globally. This scientific method has been applied in critical quality situations and workplace accidents.Ginette Collazo, Ph. D. is the author of the book Human Error: Root Cause Determination Model, published in 2008. She is also a speaker at significant events like Interphex, FDAnews Annual Conference, Global Conference on Process Safety, International Conference on Applied Human Factors and Ergonomics, and of course, Pharmaceutical Industry Association.