Event Catalog
Browse 71 professional development events
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 CollazoAI Errors May Be Impossible to Eliminate — What That Means for Its Use in the FDA
AI errors may be statistically unavoidable. Learn how to build controls, oversight, and governance models that make AI safe, compliant, and inspection-ready in FDA-regulated environments.
Dr. Ginette Collazo
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 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 Collazo
IQ, OQ, PQ in the Verification and Validation Process
Develop a Master Validation Plan and defensible IQ, OQ, PQ protocols aligned with FDA cGMP, ICH Q9, ISO 13485, and ISO 14971 risk management standards.
John E. Lincoln
Nitrosamines After the Initial Assessment: When Does a Change Trigger Reassessment and How Should Impact Be Evaluated
Master the complex decisions that follow post-approval changes — when nitrosamine reassessment is mandatory, when scientific rationale suffices, and how to evaluate NDSRI impact using CPCA under ICH M7.
G. Sundar