A practical, risk-based framework for managing continuous SaaS and AI change while maintaining compliance, validated state, and inspection readiness — without a validation backlog.
Includes live access & recording
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.
By the end of this session, attendees will be able to maintain compliance without treating every SaaS update as a full revalidation effort, implement risk-based change control that supports both compliance and business agility, and identify and control configuration drift before it creates compliance risks.
Participants will develop defensible criteria for determining when testing, revalidation, or documentation updates are necessary, reduce validation bottlenecks that consume resources and delay system improvements, and improve oversight of vendor-managed and AI-driven changes while maintaining accountability.
The result: practices aligned with FDA CSA principles and GAMP® 5 Second Edition guidance that let your organization adopt cloud and AI technologies confidently while remaining inspection-ready.
By the end of this session, attendees will be able to:
Learn how to maintain compliance without treating every SaaS update as a full revalidation effort.
Understand how to implement risk-based change control processes that support both compliance and business agility.
Gain practical methods for identifying and controlling configuration drift before it creates compliance risks.
Develop defensible criteria for determining when testing, revalidation, or documentation updates are necessary.
Reduce validation bottlenecks that consume resources and delay system improvements.
Improve oversight of vendor-managed and AI-driven changes while maintaining accountability.
Align your change management practices with FDA CSA principles, GAMP® 5 guidance, and current industry expectations.
Strengthen your organization's ability to adopt cloud and AI technologies confidently while remaining inspection-ready.
Receive practical tools and approaches that can be immediately applied to regulated SaaS and AI environments.
Focused areas that will strengthen how your organization controls change without creating validation backlogs.
Identify and control configuration drift in SaaS and AI systems before it creates compliance risk.
Apply FDA CSA principles and GAMP® 5 Second Edition guidance to scale change control to actual risk.
Differentiate vendor-controlled, customer-controlled, and shared-responsibility changes and oversee them with accountability.
Use metrics, governance, and scalable approval workflows to keep high-frequency changes from overwhelming validation resources.
A comprehensive look at managing change, configuration drift, and revalidation across SaaS and AI-enabled systems.
Everyone responsible for maintaining compliant and validated cloud-based and AI-enabled systems, including:
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
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 — and organizations must maintain compliance and validated states without creating overwhelming validation backlogs or slowing innovation.
A practical, risk-based framework for managing change in SaaS and AI systems supports identifying and controlling configuration drift, assessing the impact of vendor-driven changes, and determining when revalidation is actually required, aligned with FDA CSA principles, GAMP® 5 Second Edition guidance, and modern regulatory expectations for computerized systems and AI-enabled technologies.
Scalable approval workflows, vendor documentation and release notes, traceability practices, and governance metrics together prevent change and validation activity from becoming a backlog — while keeping organizations inspection-ready as their SaaS and AI systems continue to evolve.
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.
Don't miss this essential training on managing change control for SaaS and AI systems without creating validation backlogs. Secure your spot now.