Event Catalog

This session examines complaint handling from a lifecycle perspective, focusing on how complaint information drives downstream quality and regulatory decisions.

Meredith Crabtree

Learn how SPC, Six Sigma, and process data support CGMP production controls — sampling plan justification, verification/validation, and trend analysis for non-conformances, complaints, and CAPAs.

John E. Lincoln

Master closed-loop CAPA with repeatable failure investigation and root cause analysis tools that satisfy FDA audit expectations in GMP environments.

John E. Lincoln

Practical strategies for reducing pharmaceutical deviation backlogs without sacrificing investigation quality — covering risk-based depth, defensible closure, CAPA, and inspection readiness.

Charles H. Paul

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

Learn how to measure and improve SOP effectiveness across training, qualification, GMP operations, and AI-assisted environments — connecting documentation, compliance, and workforce performance.

Michael Esposito

Learn how SPC, Six Sigma, and process data support CGMP production controls — sampling plan justification, verification/validation, and trend analysis for non-conformances, complaints, and CAPAs.

John E. Lincoln

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

A step-by-step guide to investigating sterility test failures — covering FDA regulations, root cause tools, lot impact assessment, and audit-ready documentation.

Danielle DeLucy

Move beyond superficial root causes — build defensible deviation reports, sustainable CAPA, and change control aligned with 21 CFR 820.100 and GMP expectations.

Charles H. Paul

Manage FDA inspection close-out, Form 483 responses, CAPA commitments, and executive accountability to reduce enforcement risk and build long-term regulatory credibility.

Charles H. Paul

Master the fundamental steps of deviation investigation — use objective evidence to determine root cause, develop effective CAPA, and avoid FDA 483 observations.

Danielle DeLucy

Understand how FDA selects inspection targets, evaluates quality systems remotely, and build a continuous state of control aligned with 21 CFR regulations before the investigator arrives.

Charles H. Paul

Master closed-loop CAPA with repeatable failure investigation and root cause analysis tools that satisfy FDA audit expectations in GMP environments.

John E. Lincoln

Practical strategies for reducing pharmaceutical deviation backlogs without sacrificing investigation quality — covering risk-based depth, defensible closure, CAPA, and inspection readiness.

Charles H. Paul

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

Learn how to measure and improve SOP effectiveness across training, qualification, GMP operations, and AI-assisted environments — connecting documentation, compliance, and workforce performance.

Michael Esposito