Event Catalog
Browse 117 professional development events
Root Cause Analysis for GMP Investigations: Identifying Systemic Failures and Building Effective CAPA
Master closed-loop CAPA with repeatable failure investigation and root cause analysis tools that satisfy FDA audit expectations in GMP environments.
John E. Lincoln
Step-by-Step Process for Successful Sterility Failure Investigations
A step-by-step guide to investigating sterility test failures — covering FDA regulations, root cause tools, lot impact assessment, and audit-ready documentation.
Danielle DeLucyRoot Cause Analysis for GMP Investigations: Identifying Systemic Failures and Building Effective CAPA
Master closed-loop CAPA with repeatable failure investigation and root cause analysis tools that satisfy FDA audit expectations in GMP environments.
John E. LincolnRecording available
Determining Root Cause in Sterility Failure Investigations
A practical investigation framework for tracing sterility failures through laboratory, manufacturing, environmental, and contamination-source evidence to establish a defensible root cause, determine the impact on affected batches, and support appropriate corrective actions.