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 Mora
AI-Assisted Post-Market Surveillance and Signal Detection: What Regulators Will Still Expect Humans to Defend
AI can detect signals — but regulators will still expect humans to interpret, defend, and document post-market surveillance decisions. Learn what that looks like under FDA and EU MDR.
Meredith CrabtreeConfiguration 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 MoraFDA Labeling and UDI Essentials for Medical Products
Turn FDA labeling and UDI requirements into a controlled, inspection-ready system — cover 21 CFR 801, DMR linkage, misbranding risk, IFUs, and GUDID compliance.
José Mora
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. LincolnFDA 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. Lincoln
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. Lincoln
EO Sterilization Validation and Revalidation Under ISO 11135: Practical Implementation and Lifecycle Considerations
Learn the ISO 11135 requirements for EO sterilization validation and periodic revalidation — covering equipment IQ/OQ/PQ, overkill approach, sterile load V&V, BIs/PCDs, and lifecycle controls for medical devices.
John E. Lincoln
AI-Assisted Post-Market Surveillance and Signal Detection: What Regulators Will Still Expect Humans to Defend
AI tools can detect signals — but regulators still expect humans to interpret, escalate, and defend every post-market surveillance decision under FDA and EU MDR.
Meredith CrabtreeThe 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. Lincoln