Event Catalog
Browse 117 professional development events
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
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 Crabtree
The 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
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 CrabtreeRecording available
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 CrabtreeRecording available
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. LincolnRecording available