Event Catalog
Browse 117 professional development events
Excel Spreadsheets — Ensuring Data Integrity and 21 CFR Part 11 Compliance
Avoid FDA 483s by properly configuring and validating GxP-compliant Excel spreadsheets — with live step-by-step setup of audit trails, security features, and data entry verification.
David NettletonData 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
Acceptance Criteria for AI Validation: Determining What "Reliable" Actually Means in GxP Systems
Learn how to define meaningful, risk-based acceptance criteria for AI systems in GxP environments — covering reliability thresholds, hallucination controls, human guardrails, and CSA-aligned validation strategies.
Carolyn Troiano
Audit Trail Review by Exception: Reducing Reviewer Burden Without Weakening Detection
Learn how to implement a risk-based audit trail review-by-exception strategy that reduces reviewer fatigue while strengthening detection of critical compliance, data integrity, and cybersecurity risks.
Carolyn TroianoAnnex 22 and AI Governance for GMP: Human Review, Model Monitoring, and Change Control
Meet EU Annex 22 AI governance requirements in GMP — covering human review, model monitoring, change control, CSV vs CSA, GAMP®5, and inspection readiness for AI/ML systems.
Carolyn TroianoRisk-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 TroianoThe Smart Way to Classify Cloud GxP Systems Before You Validate — 3-Hour Course
A 3-hour course on classifying cloud GxP systems with precision using CSA — assess intended use, GxP relevance, risk, and shared responsibility before validation begins.
Carolyn TroianoCSA in Practice: How to Build Defensible Evidence the FDA Actually Wants to See
Break through CSV conditioning — learn how to build FDA-defensible evidence using CSA, size effort with risk-based thinking, and align with GAMP 5 (2nd Edition) without the paperwork burden.
Carolyn TroianoProject Management Best Practices for Computer Systems Regulated by FDA
Apply project management best practices to FDA-regulated computer system implementations — covering SDLC, CSV, GAMP V, roles, documentation, and maintaining systems in a validated state.
Carolyn TroianoLeveraging AI in Risk Assessment for Smarter Computer Systems Validation
Apply AI responsibly to CSV risk assessment — build defensible, inspection-ready risk models that align with CSA, GAMP 5, and FDA data integrity expectations.
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 TroianoRisk-Based Excel Spreadsheet Validation
Apply SDLC, GAMP 5, and risk-based validation to Excel spreadsheets used in FDA-regulated activities — covering Part 11, data integrity, and inspection preparation.
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
Annex 22 and AI Governance for GMP: Human Review, Model Monitoring, and Change Control
Meet EU Annex 22 AI governance requirements in GMP — covering human review, model monitoring, change control, CSV vs CSA, GAMP®5, and inspection readiness for AI/ML systems.
Carolyn TroianoRecording available
FDA Warning Letters & Computerized Systems: From Validation Failures to Inspection-Ready CSV/CSA
Learn what FDA warning letters reveal about software validation, data integrity, audit trails, Part 11, CSV, CSA, change control and inspection readiness.
Meredith Crabtree
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
Risk-based Excel Spreadsheet Validation - 2026 Updates
Master risk-based Excel spreadsheet validation for FDA-regulated environments — covering GAMP 5, SDLC, 21 CFR Part 11, data integrity, and inspection readiness.
Carolyn TroianoRecording available
Acceptance Criteria for AI Validation: Determining What "Reliable" Actually Means in GxP Systems
Learn how to define meaningful, risk-based acceptance criteria for AI systems in GxP environments — covering reliability thresholds, hallucination controls, human guardrails, and CSA-aligned validation strategies.
Carolyn TroianoRecording available
Audit Trail Review by Exception: Reducing Reviewer Burden Without Weakening Detection
Learn how to implement a risk-based audit trail review-by-exception strategy that reduces reviewer fatigue while strengthening detection of critical compliance, data integrity, and cybersecurity risks.
Carolyn TroianoRecording available