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Validating AI Use in Quality Systems

Practical CSV and CSA Approaches for FDA Inspection Readiness

** 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 validate AI use in quality systems with risk-based CSV and CSA methods, helping define intended use, verification expectations, human accountability, and inspection-ready documentation. This Course is designed for professionals responsible for result assessment, investigation oversight, and quality decisions that must withstand regulatory review.

  • 28 May 2026
  • Eastern Time (US/Canada): 11.00 AM
  • GMT: 3.00 PM
  • 90 Minutes
  • FDB2848
  • Carolyn Troiano
  • 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 tools are entering GxP quality systems through document drafting, summarization, analytical support, and other quality-related workflows. The challenge is that AI does not behave like traditional deterministic software. Outputs can be variable and context-dependent, making legacy CSV methods difficult to apply without creating either excessive documentation or insufficient control. That gap becomes visible when organizations cannot explain intended use, risk level, verification expectations, or human accountability.

This program focuses on practical validation and control of AI use through established CSV thinking and modern CSA principles. It addresses how intended use is defined, how AI-assisted activities are bounded, and how use cases are classified by impact on product quality, patient safety, and data integrity. The emphasis is on inspection-ready control: clear responsibilities, risk-based verification, traceable decisions, and documented oversight.

  • Define AI use before controlling it:

    AI cannot be validated meaningfully if its role in the quality system is vague. This course helps teams define intended use, set boundaries for AI-assisted activities, and distinguish document drafting, summarization, and analytical support from higher-risk process uses. That clarity becomes essential when inspectors ask how AI fits into actual workflows.

  • Apply risk-based controls without over-documenting:

    Traditional CSV can become inefficient when applied mechanically to AI behavior, while informal use creates compliance exposure. This course helps teams apply CSA principles to classify low-risk and high-risk AI use cases, select appropriate controls, and verify outputs based on impact to product quality, patient safety, and data integrity.

Key Areas Covered

  • Limitations of traditional CSV for AI and non-deterministic systems
  • Applying CSA principles to AI use within GxP quality systems
  • Defining intended use and boundaries for AI-assisted activities
  • Risk-based classification by impact to quality, safety, and data integrity
  • Differentiating low-risk and high-risk AI use cases in regulated processes
  • Designing verification expectations and supporting evidence for AI-generated outputs
  • Maintaining accountability, authorship, and human oversight in AI-assisted decisions
  • Documentation and traceability expectations aligned with ALCOA++ principles

Who Must Attend

  • QA/QC Departments
  • QA/IT and System Owners
  • Validation Specialists
  • Compliance Managers
  • Regulatory Affairs Departments
  • Quality System Leads
  • CSV & Data Integrity Specialists
COURSE DIRECTOR

Carolyn Troiano

Carolyn Troiano has more than 30 years of computer system validation experience across FDA-regulated industries and advises companies on CSV and large-scale IT implementations. She developed validation programs when FDA’s early CSV guidance emerged and collaborated with FDA and industry representatives on 21 CFR Part 11, directly supporting this topic’s focus on AI validation, control, and inspection readiness.

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.

“Examples were relatable. Not generic. We could map it to what we are currently doing.”
- Supervisor, Quality Control
“Presenter knew where to spend time and where to move quickly. That made a difference.”
- Director, Quality Assurance
“Team found it useful. Especially for aligning understanding across functions.”
- Manager, Operations

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