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AI Errors May Be Impossible to Eliminate – What That Means
for Its Use in the FDA

** Registration to this course includes Trial access to TalkFDA Subscription and Members-only Community. Contact our Support for more details after the course completion.

This course equips teams to manage AI error risk through validation, governance, monitoring, and human oversight so AI-supported activities remain controlled, explainable, and aligned with GMP and FDA expectations. This Course is designed for professionals responsible for result assessment, investigation oversight, and quality decisions that must withstand regulatory review.

  • 17 June 2026
  • Eastern Time (US/Canada): 11.00 AM
  • GMT: 3.00 PM
  • 90 Minutes
  • FDB1304
  • Dr. Ginette Collazo
  • Live Session + Post-live Continued Learning
  • Live Q&A Included
  • Presentation Handout & Templates
  • Assessment & Certification Included

REGISTRATION OPTIONS

Live session Plus Complimentary 30 Days Streaming access

$190  |  One participant (viewer)

$590  |  Team of up to 10 participants

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Why take this course?

AI systems are becoming part of regulated operations across pharmaceuticals, medical devices, and biologics, supporting activities such as predictive analytics, batch record review, deviation trending, and inspection readiness. Unlike traditional software, machine learning and generative AI operate probabilistically, which means outputs may vary, hallucinate, reflect bias, or change as models evolve. In GMP environments, even small inaccuracies can affect compliance, data integrity, and patient safety decisions.

This program focuses on what AI’s structural error potential means for regulated use. It addresses the difference between deterministic software behavior and probabilistic AI output, the limits of traditional CSV for adaptive systems, and the need for risk-based validation, monitoring, human oversight, and governance. The emphasis is not on eliminating every error, but on building controls that make AI use accountable, monitored, and inspection-ready.

  • Control AI risk without expecting perfection:

    AI outputs may vary, hallucinate, or drift, which changes how regulated teams must think about validation and oversight. This course helps participants evaluate AI as a probabilistic system and apply risk-based controls that reduce compliance exposure while preserving responsible use in GMP operations.

  • Prepare AI use for inspection questions:

    FDA scrutiny around AI-enabled tools is expected to focus on transparency, explainability, oversight, and evidence. This course strengthens how teams document governance, monitor performance drift, and explain human-in-the-loop review so AI-supported work can be addressed with clarity during audits and inspections.

Key Areas Covered

  • AI error types including hallucinations, bias, and model drift
  • Deterministic software behavior versus probabilistic AI output in GMP environments
  • FDA expectations for AI-enabled tools used in regulated operations
  • AI validation challenges compared with traditional CSV approaches
  • Risk management principles aligned with ICH Q9
  • Data integrity considerations using ALCOA+ principles
  • Governance models, human oversight, and accountability for AI use
  • AI use in deviation management, CAPA, trending, and inspection readiness

Who Must Attend

  • Quality Assurance Departments
  • Quality Control Departments
  • Regulatory Affairs Departments
  • Compliance Departments
  • CSV Professionals
  • Manufacturing Departments
  • Operations Departments
  • IT Systems Professionals
  • Validation Professionals
  • Risk Management Professionals
  • Digital Transformation Leaders
COURSE DIRECTOR

Dr. Ginette Collazo

Ginette Collazo is an Industrial-Organizational Psychologist specializing in engineering psychology and human reliability. With 20 years of experience in pharmaceutical and medical device manufacturing, she focuses on how human behavior, systems, investigations, and CAPA decisions interact. Her background supports this topic’s emphasis on oversight, accountability, and controlled decision-making around AI-supported processes.

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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.

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Your organization deserves the confidence.

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Testimonials

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“Session was easy to follow even for non-core team members. That helped.”
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