AI in GxP: Validation and Compliance

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Artificial Intelligence (AI) is increasingly being adopted across regulated pharmaceutical, biotechnology, and medical device environments. However, traditional Computer Systems Validation (CSV) approaches were not designed for data-driven, probabilistic, and evolving AI systems. Regulators now expect organizations to apply risk-based, lifecycle-oriented assurance that demonstrates AI systems are fit for their intended GxP use.

This course provides a practical, regulatory-aligned framework for validating and governing AI applications in GxP environments, consistent with FDA and EMA expectations. This AI in GxP course incorporates regulatory expectations for risk-based computer system validation and compliance for AI applications used in GxP environment. It aligns with industry-wide standards, such as those defined by GAMP and PIC/S.

Participants will learn how to apply CSV / CSA principles to AI systems, define appropriate Context of Use, assess AI-specific risks, establish credibility and validation evidence, and maintain compliance throughout the AI lifecycle.

Our Approach to AI in GxP Training

Our experienced computer system validation consultants have designed a concise, yet thorough course to equip you with the information you need to validate AI based applications. A mixture of instructor lectures, class activities, and real-world examples will keep you engaged. And there will be plenty of opportunities to get answers to your company-specific questions.

What You Get

By the end of this course, participants will be able to:

  • Understand how FDA and EMA view AI systems in regulated GxP use cases
  • Differentiate AI validation from traditional deterministic software validation
  • Define AI Context of Use (COU) and link it to regulatory decision-making
  • Perform AI-specific risk assessments, including data, model, and transparency risks
  • Apply FDA’s AI credibility assessment lifecycle to real GxP scenarios
  • Design risk-based validation strategies aligned with CSV / CSA principles
  • Establish governance, documentation, and lifecycle controls for AI systems
  • Prepare AI systems for regulatory inspection and audit readiness

Key Topics Covered

  • Regulatory landscape for AI in GxP (FDA, EMA)
  • AI system types and glossary: deterministic vs non-deterministic, static vs adaptive, ML and GenAI
  • Mapping AI systems to GxP impact and risk categories
  • FDA AI Credibility Framework: Steps 1–7 applied to CSV
  • Data integrity, dataset adequacy, bias, and representativeness
  • Model transparency, explainability, and human oversight
  • Validation evidence for AI: performance, robustness, and reliability
  • Change control, monitoring, and lifecycle management for AI
  • Inspection-ready documentation and compliance strategies

Who Should Attend?

This course is designed for:

  • IT Personnel and Managers
  • CSV Personnel and Managers
  • Quality Personnel and Managers
  • Auditors
  • AI Users
  • AI Developers
  • Data Analysts and Science Leaders
  • Vendors and solution providers of GxP AI systems

Materials Provided:
Course binder, example AI validation package, Training Certificate

Duration: 12 hours

Cost: $1199 per student

Group Pricing: Enroll two students at full price and receive a third seat FREE.

We Are Offering This Course on the Following Dates:

 

Private Session: We can bring this course to you. Save travel costs and select the dates that work for your team. Private classes start at $5,500 for up to twelve (12) students. Contact Us for larger group pricing, additional questions, or to schedule your session.