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ON-DEMAND FDA Compliance

Supervising a Human Error Free Environment: You can do a Lot More than you Think

Learn how supervision causes and prevents human error, find root causes and CAPA for supervision-related errors, and measure, trend and predict error rates in GMP settings.

FormatRecorded sessionWatch any time
Length90 minutes
Ginette M. Collazo Speaker Ginette M. Collazo Industrial-organizational psychologist · Human Error Solutions · Ph.D., I-O psychology
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Overview

People make mistakes because systems let them. Reducing human error means understanding behavior and the psychology of error, and knowing exactly where your systems are weak.

This 90-minute human error reduction training focuses on the supervisor's role. You'll learn why supervision matters so much in preventing errors, how to find near root causes and root causes of supervision-related errors, and the five main elements of an error-free environment.

The session covers memory failures, overconfidence, visual detection and vigilance, plus error types, error rates and measurement, trending, prediction and CAPA effectiveness. You'll leave with practical tools to use on the floor in GMP environments.

Why attend: Preparation, planning, scheduling and communication by supervisors all affect how often errors happen. This course gives practical approaches for floor supervision, ways to get your group in sync, and a method to correct, prevent and avoid repeat issues in GMP environments. It suits supervisors, managers and directors in operations, manufacturing and plant engineering, QA/QC staff, process improvement and industrial engineers, compliance and regulatory professionals, and corporate counsel.

What’s covered

  • Background on human error
  • What human error is
  • Why preventing and reducing human error matters
  • Supervision and human error
  • Human errors caused by supervisors and how to avoid them
  • When operator error is the root cause
  • How supervision controls human error
  • Common mistakes: memory failures, overconfidence, visual detection and vigilance, and how supervision helps
  • Types of error
  • Human error rates and measurement
  • Trending and tracking
  • Prediction
  • CAPA effectiveness

Who should attend

Supervisors, managers, and directorsOperationsManufacturingPlant engineeringQA/QC staffProcess excellence/improvement professionalsIndustrial/process engineersCompliance officersRegulatory/legislative affairs professionalsGeneral/corporate counsel

What you get

CertificateEmailed to each attendee after the session.
HandoutsSlides and checklists to reuse with your team.

About the speaker

Ginette M. Collazo
Ginette M. Collazo
Industrial-organizational psychologist · Human Error Solutions

Ginette Collazo, Ph.D. is an Industrial-Organizational Psychologist with 20 years of experience that specializes in Engineering Psychology and Human Reliability, disciplines that study the interaction between human behavior and productivity. She has held positions leading training and human reliability programs in the Pharmaceutical and Medical Device Manufacturing Industry.Nine years ago, Dr. Collazo established Human Error Solutions (HES), a Florida based boutique consulting firm, where she has been able to position herself as one of the few Human Error Reduction Experts in the world. HES, led by Dr. Collazo, developed a unique methodology for human error investigations, cause determination, CA-PA development and effectiveness that has been implemented and proven amongst different industries globally. This scientific method has been applied in critical quality situations and workplace accidents.Ginette Collazo, Ph. D. is the author of the book Human Error: Root Cause Determination Model, published in 2008. She is also a speaker at significant events like Interphex, FDAnews Annual Conference, Global Conference on Process Safety, International Conference on Applied Human Factors and Ergonomics, and of course, Pharmaceutical Industry Association.

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