Validation of Artificial Intelligence (AI), Machine Learning (ML), And Other Superintelligence Based GXP Systems

  • Instructor : Carolyn Troiano
  • Level : Intermediate
  • Study time : 104 minutes
  • Course ID: TF3645
  • Included in Subscription Pack
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ABOUT THE COURSE

Are you prepared to validate AI and ML applications within your GxP environment?
Do you know how to align intelligent systems with FDA Part 11 and data integrity expectations?
Is your team ready to manage the risk, complexity, and scrutiny AI brings to life sciences?


This training simplifies the complex world of AI/ML validation—giving you clear strategies to ensure regulatory compliance, manage evolving risks, and future-proof your GxP systems.


WHAT WILL YOU GAIN
  • A step-by-step approach for validating AI/ML technologies in FDA-regulated systems
  • Clear understanding of how to align intelligent automation with Part 11 and SDLC
  • Tools to mitigate risk and ensure compliance across rapidly evolving AI-enabled systems


WHY TAKE THIS COURSE
  • AI/ML is redefining the industry—and regulators are paying close attention
  • FDA citations related to data integrity and audit trails are surging
  • This course bridges cutting-edge innovation with regulatory compliance realities


KEY AREAS COVERED
  • AI/ML use in life sciences and how it impacts product quality and patient safety
  • FDA’s evolving stance on AI-enabled devices and software lifecycle validation
  • How to validate, document, and monitor AI/ML systems using risk-based SDLC
  • Managing compliance with 21 CFR Part 11 and data integrity in AI environments
  • Cybersecurity, audit readiness, and vendor oversight for intelligent systems
  • Industry best practices for operationalizing AI with full GxP and regulatory control

Quality training, expert insights, and answers that matter. Know your Expert

CAROLYN TROIANO

Carolyn Troiano brings over three decades of unmatched expertise in computer system validation across FDA-regulated industries. A trusted pioneer in 21 CFR Part 11 strategy and implementation, she has helped top pharma, biotech, and med device companies integrate compliance into modern systems. Her experience with AI validation and regulatory expectations makes her the go-to expert for bridging innovation with FDA readiness.

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