Event Catalog
Browse 71 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
Human Error Investigation Program — Effective Implementation
Implement a proven human error investigation methodology — classify error categories, identify root causes, develop effective CAPA, and apply Human Factors to prevent recurring GMP issues.
Dr. Ginette CollazoDeviation Backlog Reduction: Balancing Investigation Depth, Closure Speed, and Justifiable Decisions
Practical strategies for reducing pharmaceutical deviation backlogs without sacrificing investigation quality — covering risk-based depth, defensible closure, CAPA, and inspection readiness.
Charles H. Paul
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 DeLucyAI for CAPA and Investigations: Where It Helps and Where It Can Get You in Trouble
Learn where AI genuinely helps CAPA and investigations — and where it creates regulatory risk by replacing evidence-based analysis with generated logic.
Charles H. Paul
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 CrabtreeSuccessfully Investigating Deviations
Master the fundamental steps of deviation investigation — use objective evidence to determine root cause, develop effective CAPA, and avoid FDA 483 observations.
Danielle DeLucy