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. LincolnUsing SPC and Process Data to Support Quality, Stability, and Manufacturing Decisions
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
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 CollazoFDA Inspection Readiness: Building a Defensible State of Control Before the Investigator Arrives
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. PaulDeviation 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. PaulMeasuring SOP Effectiveness Across Training, Qualification, GMP Operations, and AI-assisted environments
Learn how to measure and improve SOP effectiveness across training, qualification, GMP operations, and AI-assisted environments — connecting documentation, compliance, and workforce performance.
Michael EspositoDeviations, CAPA and Change Control
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. PaulInspection Close-Out, Enforcement Risk, and Long-Term FDA Relationship Management
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. PaulSuccessfully 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