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

  • Date
    01 July 2026
  • 11.00 AM Eastern Time (US/Canada)
    03.00 PM GMT

Course is now LIVE. Click below to join the session.

This course helps teams convert AI adoption from an uncontrolled technology initiative into a quality-managed activity with clear validation, oversight, documentation, change control, and inspection readiness expectations. Designed for professionals managing digital quality systems, AI-enabled workflows, computerized processes, compliance oversight, or operational decisions influenced by automated technologies.

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REGISTRATION OPTIONS

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Complimentary 30 Days Streaming access

$290  |  One participant (viewer)

$390  |  Team (2 - 5 participants)

$490 |  Team (6 - 10 participants)

REGISTER FOR THE COURSE

US $290 per learner

30-Days Unlimited Streaming Access

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REGISTER FOR THE COURSE

To Get 30-Day Access to ONLY this Course 

US $290 per learner
  • This course is Included in Subscription Pack
Subscription include access to entire Learning Library
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  • Faculty
    Dr. Ginette Collazo
  • Duration
    90 Minutes
  • Course ID
    TF1305
  • Live Q&A +
    Post-live Continued Learning
  • Presentation Handout
    & Templates
  • Assessment
    & Certification Included

 

Why take this course?

AI adoption is moving into regulated quality operations, including automated quality reviews, predictive maintenance, complaint handling, CAPA management, and AI-assisted decision processes. The FDA’s first AI-related Warning Letter signals that AI-enabled activities cannot sit outside the Quality Management System. They must be validated, controlled, monitored, documented, and governed with the same seriousness expected for other GMP-impacting systems.


For quality, regulatory, validation, IT, and operational teams, the issue is no longer whether AI can support efficiency, but whether its use can withstand regulatory review. Data integrity, validation, risk management, change control, supplier oversight, human accountability, cybersecurity, bias, hallucinations, and model drift all become quality system concerns when AI affects regulated decisions. This webinar addresses how organizations can integrate AI into existing QMS processes while reducing compliance gaps and preparing for FDA inspection questions involving AI-driven technologies.

Clearer AI Quality System Control

Organizations using AI in complaints, CAPA, deviations, quality reviews, or operational decisions need more than technical confidence. They need quality system control. This course strengthens the ability to identify where validation, monitoring, documentation, human oversight, and accountability must be built into AI-enabled processes before inspection questions arise.

Stronger Readiness for AI-Related FDA Scrutiny

The first AI-related Warning Letter shows that FDA expectations are already moving from theory to enforcement. Participants gain practical judgment for evaluating AI risks such as bias, cybersecurity, hallucinations, and model drift, while aligning supplier qualification, lifecycle management, and change control with regulated quality operations.

Key Areas Covered

  • Significance of the FDA’s first AI-related Warning Letter for GMP-regulated organizations
  • AI governance and integration within existing Quality Management System processes
  • CSV and AI validation considerations for regulated systems and decision workflows
  • Data integrity, audit trail expectations, and documentation controls for AI systems
  • Managing AI risks including bias, hallucinations, cybersecurity, and model drift
  • Change control, lifecycle management, and monitoring of AI-enabled applications
  • Human oversight, accountability, and deviation management in AI-assisted processes
  • Supplier qualification and third-party AI vendor oversight for inspection readiness

Who Must Attend

  • Quality Assurance
  • Regulatory Affairs
  • Validation and Computer System Validation (CSV) Specialists
  • Compliance Officers
  • Manufacturing and Operations
  • 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
COURSE DIRECTOR

Dr. Ginette Collazo

Ginette Collazo, Ph. D. has 20 years of experience in Engineering Psychology, Human Reliability, training, and human error reduction within pharmaceutical and medical device manufacturing. Her work in investigations, cause determination, CAPA development, effectiveness, and critical quality situations connects directly to AI oversight, human accountability, deviation handling, and quality system control.

If you would like to request a Proforma invoice to sign up for this course. please click here

Ready to Strengthen Your Team? Let’s Build Your Training Plan.

Whether you’re looking for a single onsite workshop or a multi-team training series, we’ll help you design a program that fits your goals, timelines, and operational reality.

Your team deserves the clarity.
Your organization deserves the confidence.

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Testimonials

This is an upcoming session. Feedback below reflects experiences from similar programs delivered by our expert faculty.

“Session was easy to follow even for non-core team members. That helped.”
- Production Officer
“Good balance. Not too basic, not too deep. Worked well for mixed team.”
- Manager, Regulatory Affairs
“Team found it useful. Especially for aligning understanding across functions.”
- Director, Operations

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