Event Catalog
Browse 117 professional development events
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 Collazo
GMP 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. PaulInspection Close-Out, Enforcement Risk, and Long-Term FDA Relationship Management
Manage FDA inspection close-out, Form 483 responses, CAPA commitments, and executive accountability to reduce enforcement risk and build long-term regulatory credibility.
Charles H. PaulThe 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
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