Event Catalog
Browse 117 professional development events
Configuration Control vs. Document Control – Managing Design Changes Across Modern Quality Systems
Learn why Configuration Architecture — not Document Control — defines the modern Quality System, and how treating relationships as first-class objects strengthens traceability, change control, and inspection readiness.
José MoraQMSR Device Records: Structuring DDF, MDF and Related Relationships for Inspection Readiness
Learn how to structure QMSR Device Records using Lean Documents and Lean Configuration principles to achieve true inspection readiness through relationship integrity, not just document control.
José Mora
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
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 TroianoDeviation Backlog Reduction: Balancing Investigation Depth, Closure Speed, and Justifiable Decisions
Practical strategies for reducing pharmaceutical deviation backlogs without sacrificing investigation quality — covering risk-based depth, defensible closure, CAPA, and inspection readiness.
Charles H. PaulUsing EU GMP Annex 22 as the Framework for Governing AI Systems, Validation Traceability, and Data Integrity Controls
Learn how to apply EU GMP Annex 22 as a practical framework for AI system governance, validation traceability, lifecycle management, and data integrity controls in regulated pharmaceutical and biotech environments.
Charles H. PaulAI and Decision Making in GMP: Resolving Conflicts Between Human Judgment and AI Recommendations
Learn how to govern AI-assisted decisions in GMP operations — when to trust AI recommendations, when human judgment must override them, and how to document it all for inspection readiness.
Dr. Ginette Collazo
AI in GMP: What the FDA Is Already Expecting - Before You Ask
FDA already expects GMP compliance for AI systems. Learn how existing validation, data integrity, and oversight rules apply—before regulators come calling.
Dr. Ginette Collazo
The First FDA Warning Letter on AI: What It Means for Your Quality System
The FDA issued its first AI-related Warning Letter. Learn what it means for your QMS, validation requirements, and how to keep your quality systems inspection-ready.
Dr. Ginette CollazoRisk-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
Part 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 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 TroianoGMP 101 and Inspection Readiness
Establish the mindset for modern GMP compliance — understand how FDA inspects, why documentation gaps become findings, and how to build inspection-ready systems.
Charles H. PaulHuman Behavior Under FDA Scrutiny: How Words, Actions, and Reactions Shape Inspection Outcomes
Understand how FDA investigators use behavior as evidence of system control — learn how verbal responses, role-based interactions, and behavioral triggers shape inspection outcomes.
Charles H. Paul
Good Clinical Practices (GCP) Audit and Inspection Readiness
Build GCP audit and inspection readiness — cover QMS, SOPs, documentation, internal audits, and personnel training to ensure compliant clinical trial execution.
Charles H. PaulFDA Inspection Readiness: Building a Defensible State of Control Before the Investigator Arrives
Understand how FDA selects inspection targets, evaluates quality systems remotely, and build a continuous state of control aligned with 21 CFR regulations before the investigator arrives.
Charles H. PaulAI in GMP: What the FDA Is Already Expecting - Before You Ask
FDA already expects GMP compliance for AI systems. Learn how existing validation, data integrity, and oversight rules apply—before regulators come calling.
Dr. Ginette CollazoRecording available
QMSR Device Records: Structuring DDF, MDF and Related Relationships for Inspection Readiness
Learn how to structure QMSR Device Records using Lean Documents and Lean Configuration principles to achieve true inspection readiness through relationship integrity, not just document control.
José MoraRecording 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
The First FDA Warning Letter on AI: What It Means for Your Quality System
The FDA issued its first AI-related Warning Letter. Learn what it means for your QMS, validation requirements, and how to keep your quality systems inspection-ready.
Dr. Ginette CollazoRecording available
GCP E6(R3): What Inspectors Will Test in Sponsor Oversight
This course helps sponsors establish a clearer oversight strategy, align supplier arrangements with ICH-GCP E6(R3), and prepare documentation and contractual evidence that supports inspection readiness.
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 TroianoAI and Decision Making in GMP: Resolving Conflicts Between Human Judgment and AI Recommendations
Learn how to govern AI-assisted decisions in GMP operations — when to trust AI recommendations, when human judgment must override them, and how to document it all for inspection readiness.
Dr. Ginette CollazoRecording available
Configuration Control vs. Document Control – Managing Design Changes Across Modern Quality Systems
Learn why Configuration Architecture — not Document Control — defines the modern Quality System, and how treating relationships as first-class objects strengthens traceability, change control, and inspection readiness.
José MoraRecording available
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
Deviation Backlog Reduction: Balancing Investigation Depth, Closure Speed, and Justifiable Decisions
Practical strategies for reducing pharmaceutical deviation backlogs without sacrificing investigation quality — covering risk-based depth, defensible closure, CAPA, and inspection readiness.
Charles H. PaulRecording available
Using EU GMP Annex 22 as the Framework for Governing AI Systems, Validation Traceability, and Data Integrity Controls
Learn how to apply EU GMP Annex 22 as a practical framework for AI system governance, validation traceability, lifecycle management, and data integrity controls in regulated pharmaceutical and biotech environments.
Charles H. PaulRecording available