Event Catalog
Browse 71 professional development events
FDA 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. PaulGMP 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. PaulDeviations, CAPA and Change Control
Move beyond superficial root causes — build defensible deviation reports, sustainable CAPA, and change control aligned with 21 CFR 820.100 and GMP expectations.
Charles H. PaulFDA Registration, Listing & Facility Licensing — Common Pitfalls and Best Practices
Cut through recurring FDA registration, listing, and facility licensing errors — avoid misclassifications, missed updates, and common pitfalls under 21 CFR Part 807 and Part 820.
Meredith Crabtree