Event Catalog
Browse 117 professional development events
Complaint Handling and Investigation: Linking CAPA, MDR Reporting, Trend Evaluation, and Recall Considerations
This session examines complaint handling from a lifecycle perspective, focusing on how complaint information drives downstream quality and regulatory decisions.
Meredith Crabtree
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. LincolnDeviation 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. PaulAI 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 CrabtreeRepeat Deviations and OOS: Strengthening RCA-CAPA Effectiveness and Managing Investigation Backlogs | Risk-Based Decisions on When to Investigate Deeper, Escalate, or Close
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 Collazo
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 DeLucySuccessfully 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 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.
Deviation 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. PaulRecording available
AI 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. PaulRecording 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