Event Catalog
Browse 117 professional development events
Data Integrity: What Exactly Is Required for 21 CFR Part 11, SaaS/Cloud, EU GDPR
Get complete clarity on 21 CFR Part 11, Annex 11, SaaS/Cloud compliance, AI software validation, and EU GDPR requirements for regulated industries.
David Nettleton
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's 21 CFR Part 11 Add-On Inspections
Navigate FDA's increased scrutiny of electronic records and software validation — implement effective 21 CFR Part 11 V&V strategies aligned with GAMP, ISO 14971, and real-world inspection expectations.
John E. LincolnData Integrity: What Exactly Is Required for 21 CFR Part 11, SaaS/Cloud, EU GDPR
Get complete clarity on 21 CFR Part 11, Annex 11, SaaS/Cloud compliance, AI software validation, and EU GDPR requirements for regulated industries.
David NettletonRecording available
FDA Warning Letters & Computerized Systems: From Validation Failures to Inspection-Ready CSV/CSA
Learn what FDA warning letters reveal about software validation, data integrity, audit trails, Part 11, CSV, CSA, change control and inspection readiness.
Meredith Crabtree