Change Control for SaaS and AI Systems: Managing Configuration Drift and Revalidation Without Creating Validation Backlogs
Instructor
Carolyn Troiano
What You'll Learn
About the event
About this event
Traditional change control processes were designed for static, on-premise systems with infrequent updates. Today's SaaS platforms and AI-enabled applications operate in a rapidly evolving environment where software updates, configuration changes, vendor releases, model updates, integrations, and cloud infrastructure modifications occur continuously. Organizations must maintain compliance and validated states without creating overwhelming validation backlogs or slowing innovation.
This webinar provides a practical, risk-based framework for managing change in SaaS and AI systems while maintaining regulatory compliance and inspection readiness. Participants will learn how to identify and control configuration drift, assess the impact of vendor-driven changes, determine when revalidation is required, and implement efficient change management strategies that align with FDA CSA principles, GAMP® 5 Second Edition guidance, and modern regulatory expectations for computerized systems and AI-enabled technologies.
Who Should Attend
Quality Assurance Departments, Validation and CSA Practitioners, IT and Digital Transformation Leaders, System Owners, Data Integrity Specialists, Compliance Managers, CSV Professionals, AI Governance Teams, Regulatory Affairs Departments, Everyone responsible for maintaining compliant and validated cloud-based and AI-enabled systems.
Areas Covered
Meet Your Instructor
Carolyn Troiano
Carolyn Troiano has more than 45 years of experience in computer system validation in the pharmaceutical, medical device, biotechnology, tobacco, and other FDA-regulated industries. She is currently an independent consultant, advising companies on FDA compliance, Computer System Validation (CSV), and large-scale IT system implementation projects. Carolyn participated in the FDA/Industry Partnership to develop 21 CFR Part 11, the FDA’s Guidance for Electronic Records and Electronic Signatures. During her career she has provided consulting and training, including CSV, 21 CFR Part 11, Data Integrity, and many other related compliance topics of interest to the life science industries.
Event Details
Format
Live Webinar
Duration
1.5 hours
Certificate
Included
Date
Thursday, October 29, 2026
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