Event Catalog
Browse 71 professional development events
Quality Metrics & KPIs: How to Measure What the FDA Actually Cares About
Understand the latest global regulatory requirements for quality metrics and KPIs — learn to implement, align, and report metrics that satisfy FDA inspection scrutiny.
Meredith Crabtree
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 TroianoFDA Inspections After QMSR: What Replaces QSIT 2.0 — The New Inspection Reality
Understand the new QMSR inspection reality — what replaces QSIT, how FDA will inspect under ISO 13485 alignment, and how to manage the hybrid compliance burden of QSR + QMSR.
John E. LincolnFDA 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. 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. Paul
Human 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