Event Catalog
Browse 117 professional development events
Analytical Lifecycle Management Under ICH Q14 and Q2(R2): What Changes Operationally
Understand the operational impact of ICH Q14 and Q2(R2) on analytical method development, validation, transfer, and lifecycle management in regulated pharmaceutical environments.
Meredith Crabtree
OOS Investigations: Decision-Making in Practice and FDA Expectations for 2026
Learn how to interpret OOS results, recognize signals, and align investigation decisions with current FDA expectations under 21 CFR Part 211.
Meredith CrabtreeStatistical Process Control (SPC) and Control Charts for Laboratory Compliance
Use SPC and control charts to build a proactive laboratory compliance system — monitor performance variables, apply Nelson Rules, and align with 21 CFR Part 211.160 and ISO 17025.
Dr. John C. FetzerHuman Error and Documentation Practices in Good Laboratory Practices (GLP)
Navigate human error, documentation pitfalls, and GLP requirements — learn how accurate record-keeping supports data integrity, research reproducibility, and regulatory compliance.
Charles H. PaulAnalytical 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
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.
Analytical Lifecycle Management Under ICH Q14 and Q2(R2): What Changes Operationally
Understand the operational impact of ICH Q14 and Q2(R2) on analytical method development, validation, transfer, and lifecycle management in regulated pharmaceutical environments.
Meredith CrabtreeRecording available
OOS Investigations: Decision-Making in Practice and FDA Expectations for 2026
Learn how to interpret OOS results, recognize signals, and align investigation decisions with current FDA expectations under 21 CFR Part 211.
Meredith CrabtreeRecording available