Live Webinar

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

Course Information

Course Type: Live Webinar
Course ID: LSP3246
Date: October 29, 2026
US Eastern Time: 12:00 PM EDT
GMT: 4:00 PM GMT
Duration: 90 Minutes
Presenter: Carolyn Troiano

Registration Options

Date: October 29, 2026
US Eastern Time: 12:00 PM EDT
GMT: 4:00 PM GMT
Duration: 90 Minutes

Individual: USD 290.00
Team 2–5: USD 390.00
Team 6–10: USD 490.00

About the Course

This course helps teams control frequent SaaS and AI changes through risk-based impact assessment, clearer revalidation criteria, scalable approval workflows, and stronger oversight of vendor-driven changes without creating unnecessary validation backlogs.

Key Areas Covered

Configuration drift and its impact on validated systems
Vendor-controlled, customer-controlled, and shared-responsibility changes
Risk-based impact assessments for releases, patches, and feature updates
AI model updates, retraining activities, and algorithm changes
Revalidation, regression testing, and documentation update criteria
FDA CSA principles and GAMP® 5 Second Edition lifecycle guidance
Change control for integrations, APIs, middleware, and connected platforms
Vendor assurance evidence, traceability, approval workflows, and backlog prevention

Who Should Attend

Quality Assurance Departments
Regulatory Affairs Departments
IT and Digital Transformation Departments
Manufacturing and Operations Departments
CSV and CSA Specialists
System Owners and Subject Matter Experts
Data Integrity Specialists
AI Governance Teams
Compliance and Audit Managers
SaaS and Cloud Service Providers
Vendors and Consultants Supporting GxP Systems

Presenter

Carolyn Troiano

Carolyn Troiano has more than 45 years of experience in computer system validation across pharmaceutical, medical device, biotechnology, and other FDA-regulated industries. Her consulting and training work spans FDA compliance, CSV, 21 CFR Part 11, Data Integrity, and large-scale IT implementations, directly supporting the risk-based validation and modern GxP system considerations addressed in this course.