Event Catalog
Browse 71 professional development events
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 MoraConfiguration 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 Mora
CSA 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 Troiano
Onboarding In A GMP Environment — Best Practices
Build a compliant and effective GMP onboarding program — cover training coordination, contractor vs. employee differences, and how to reduce the compliance learning curve.
Michael Esposito
Analytical Method Validation under Good Laboratory Practices (GLPs)
Master analytical method validation under GLP — covering statistical requirements, selectivity, stability assessment, reagent comparison, and FDA compliance for pharmaceutical laboratories.
Dr. John C. Fetzer
Beyond Digital Batch Records: Managing FDA and EU GMP Documentation While Preserving Data Integrity
Learn how digital/electronic DHF, DMR, DHR, and EU MDR Technical Documentation improves data integrity, reduces human error, and simplifies global regulatory compliance.
John E. LincolnAcceptance Criteria for AI Validation: Determining What "Reliable" Actually Means in GxP Systems
Learn how to define meaningful, risk-based acceptance criteria for AI systems in GxP environments — covering reliability thresholds, hallucination controls, human guardrails, and CSA-aligned validation strategies.
Carolyn TroianoThe FDA Medical Device File (DHF, DMR, DHR, Market Authorizations) and EU MDR Technical Documentation
Navigate FDA DHF, DMR, DHR, and EU MDR Technical Documentation requirements — understand the similarities, differences, and how to align global medical device documentation.
John E. LincolnFDA 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