Event Catalog
Browse 117 professional development events
Data Integrity: What Exactly Is Required for 21 CFR Part 11, SaaS/Cloud, EU GDPR
Get complete clarity on 21 CFR Part 11, Annex 11, SaaS/Cloud compliance, AI software validation, and EU GDPR requirements for regulated industries.
David Nettleton
Risk-Based CSV/CSA for Modern GxP Systems: Making Defensible Validation Decisions in Practice
A two-day, risk-based framework for CSV/CSA and GAMP® 5 validation decisions on modern GxP systems — cloud, SaaS, configurable, and AI-enabled platforms — built for inspection readiness.
Carolyn Troiano
Change Control for SaaS and AI Systems: Managing Configuration Drift and Revalidation Without Creating Validation Backlogs
Risk-Based CSV/CSA for Modern GxP Systems: Making Defensible Validation Decisions in Practice
A two-day, risk-based framework for CSV/CSA and GAMP® 5 validation decisions on modern GxP systems — cloud, SaaS, configurable, and AI-enabled platforms — built for inspection readiness.
Carolyn TroianoPart 11, Data Integrity & Documentation for SaaS/PaaS Validation — 3-Hour Course
A 3-hour deep dive into 21 CFR Part 11 and data integrity for SaaS/PaaS cloud systems — covering audit trails, shared responsibility, change management, and FDA inspection readiness.
Carolyn TroianoThe CSA Playbook for SaaS, PaaS & Modern Digital Platforms — 3-Hour Course
A 3-hour CSA playbook for SaaS and PaaS validation — learn to evaluate vendor evidence, interpret SOC reports, separate responsibility, and build FDA-defensible documentation.
Carolyn TroianoCybersecurity Expectations for GxP Systems
Translate FDA cybersecurity expectations into inspection-ready GxP actions — covering SDLC touchpoints, cloud/SaaS responsibilities, access control, and audit trail requirements.
Carolyn TroianoData Integrity: What Exactly Is Required for 21 CFR Part 11, SaaS/Cloud, EU GDPR
Get complete clarity on 21 CFR Part 11, Annex 11, SaaS/Cloud compliance, AI software validation, and EU GDPR requirements for regulated industries.
David NettletonRecording available
SaaS & AI Change Control: Keep Your Validated Systems Under Control Without Revalidating Everything
Learn how to manage SaaS updates, configuration drift, vendor releases and AI model changes using risk-based change control—without turning every update into a full revalidation project.
Carolyn Troiano