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

An examination of how FDA enforcement actions are shaping expectations for AI validation, quality system integration, documentation practices, and operational accountability.

EXCLUSIVE: Get your team to

attend for just $ 390.

Individual registrations available too.

COURSE OVERVIEW & STRUCTURE

FDA scrutiny of AI is no longer theoretical. The assumptions have changed.

Organizations evaluating AI use must determine whether existing quality systems adequately address validation, accountability, documentation, and technology oversight expectations. This session structures the regulatory significance of AI-related enforcement actions and their implications across quality operations, governance, lifecycle management, and inspection readiness.

The session begins with the regulatory significance of the first AI-related Warning Letter and then examines how existing FDA expectations apply to AI-enabled activities. Discussion progresses through validation, data integrity, supplier oversight, change management, accountability, and quality system integration using practical operational examples.

WHAT YOU’LL LEARN

Applying FDA enforcement lessons to AI systems

Analysis of the first FDA AI-related Warning Letter
AI governance within GMP quality systems
CSV and AI validation expectations
Data integrity and audit trail considerations
Managing bias, hallucinations, and model drift
Change control for AI-enabled applications
Human accountability in AI-assisted processes
Supplier qualification and AI vendor oversight

WHO SHOULD ATTEND

Designed for professionals responsible for evaluating, implementing, governing, reviewing, or inspecting AI-enabled regulated processes.

Quality Assurance

Regulatory Affairs

Validation

Data Integrity

Systems Validation

SOP Management

Risk Management

Manufacturing

Inspection Readiness

Digital Transformation

FACULTY

Dr. Ginette Collazo

Dr. Collazo combines expertise in human reliability, quality systems, root cause analysis, and GMP operations with extensive experience evaluating how technology influences regulated processes. Her work investigating performance failures, developing corrective actions, and improving operational control provides relevant perspective on integrating AI into quality systems under increasing regulatory scrutiny.

AFTER YOU REGISTER

Everything related to your course lives in one place.

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After you register your seat, our team organizes everything for you; from access to certification – “from one place”.

You receive a confirmation and your course appears instantly in your TalkFDA dashboard.
Your course page becomes your central hub where you can join the session, access materials, and manage your learning.
At the scheduled time, simply click Join Session and you’ll be connected to the live Webex session with the instructor.
After the session, the playback becomes available on the same course page so you can revisit important sections.
Complete the course and your certificate is unlocked automatically in your learning history.

For Teams Seeking Deeper Implementation Support

Customized training is also available through

TalkFDA Elite Training Labs.

This topic can also be delivered as a customized session through TalkFDA Elite Training Labs for organizations seeking structured, implementation-focused training aligned with their internal processes and quality systems.

Elite Training Labs sessions are tailored for teams and delivered in formats designed to support application, discussion, and practical integration beyond the live webinar format.

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

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