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

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Ginette M. Collazo

Speaker: Ginette M. Collazo

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FDA Compliance Webinar Image
Date
02 August, 2026 (Sunday)
Time
10:00 AM PDT | 01:00 PM EDT
Duration
60 Minutes

Overview

Artificial Intelligence (AI) is rapidly transforming regulated industries, from automated quality reviews and predictive maintenance to complaint handling and CAPA management. However, with innovation comes regulatory scrutiny. The FDA’s first Warning Letter involving the use of AI has become a defining moment for GMP-regulated organizations, signaling that regulators expect AI-enabled processes to be validated, controlled, monitored, and fully integrated into the organization’s Quality Management System (QMS).

This webinar explores the implications of FDA enforcement actions related to AI and explains what organizations must do to maintain compliance while adopting advanced technologies. Participants will gain insight into how FDA expectations for data integrity, validation, risk management, change control, and oversight apply to AI-driven systems and decision-making processes.

The session will also discuss practical approaches for integrating AI into existing quality systems without compromising regulatory compliance. From supplier qualification and algorithm validation to human oversight and deviation management, attendees will learn how to proactively prepare for FDA inspections and avoid compliance gaps.

By understanding the regulatory landscape surrounding AI, organizations can confidently leverage innovation while maintaining patient safety, product quality, and operational excellence.

Area Covered

  • Overview of the FDA’s First AI-Related Warning Letter.
  • Regulatory Expectations for AI in GMP-Regulated Industries.
  • AI Governance and Quality System Integration.
  • 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 Third-Party AI Vendor Oversight.
  • Inspection Readiness and Documentation Best Practices.
  • Future Trends in FDA Regulation of Artificial Intelligence.

Why Should You Attend

AI adoption in regulated industries is accelerating, but many organizations remain unclear about FDA expectations regarding validation, oversight, documentation, and risk management. The FDA’s first AI-related Warning Letter demonstrates that regulators are closely evaluating how companies implement and control AI-enabled systems within their quality operations.

This session provides practical guidance for understanding the compliance risks associated with AI and the steps organizations should take to ensure their quality systems remain inspection-ready.

Who Will Benefit?

Professionals responsible for quality, compliance, validation, digital transformation, and regulatory oversight in regulated industries, including:
  • 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.

Speaker

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.

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