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Change Control for SaaS and AI Systems: Managing Configuration Drift and Revalidation Without Creating Validation Backlogs

4.8(0 reviews)
1.5 hoursThursday, October 29, 2026

Instructor

Carolyn Troiano

What You'll Learn

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.

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

Regulatory expectations for change control in SaaS, cloud-based, and AI-enabled systems
Applying FDA Computer Software Assurance (CSA) principles to change management activities
GAMP® 5 Second Edition guidance on modern change and lifecycle management
Understanding configuration drift and its impact on validated systems
Differentiating vendor-controlled, customer-controlled, and shared-responsibility changes
Risk-based impact assessments for SaaS releases, patches, and feature updates
Managing AI model updates, retraining activities, and algorithm changes
Determining when revalidation, regression testing, or documentation updates are required
Establishing scalable approval workflows for high-frequency system changes
Leveraging vendor documentation, release notes, and assurance evidence
Maintaining traceability and validation status in continuously evolving systems
Change control strategies for integrations, APIs, middleware, and connected platforms
Metrics and governance approaches to prevent change and validation backlogs
Inspection readiness considerations and documentation expectations
Case studies demonstrating effective management of SaaS and AI system changes

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.

Quantity
1

Single: 1 Attendee

$240.00
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Certificate of completion

Event Details

Format

Live Webinar

Duration

1.5 hours

Certificate

Included

Date

Thursday, October 29, 2026

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