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Training Doyens is recognized by SHRM to offer Professional Development Credits (PDCs) for SHRM-CP or SHRM-SCP. This program is valid for 3 PDC for the SHRM-CP or SHRM-SCP. For more information about certification or recertification, please visit shrmcertification.org.

OVERVIEW

This course offers practical approaches and tools for human error reduction and prevention in GMP related environments by using a particular methodology for human error assessments, correction, prevention and avoidance of reoccurrence of these matters.

WHY SHOULD YOU ATTEND

Human error is known to be the primary cause of quality and production losses in many industries. Although it is unlikely that human error will ever be eliminated, many human performance problems can be prevented. Human errors start at the design stage.

From procedures, training, and workplace environment many variables that affect human behavior CAN be manipulated reducing the likelihood of these occurrences.

When working with these challenges, it is imperative to understand human behavior, human error metrics and the psychology of error as well as understand exactly where the weaknesses of the system are so that they can be improved and fixed.

AREAS COVERED

• Background on human error phenomena and human error measurement
• The importance of human error prevention/reduction
• Quantitative and qualitative information gathering
• Why do we need tools for human error reduction programs?
• Facts about human error and training
• Human error as the root cause: what to do and how to measure it?
• Tools
• Prediction
• Root Cause Analysis
• Cognitive load assessment
• Systems available
• Human error rate
• Floor checklist
• Interview questions
• Human error rates and other metrics
• Trending and tracking
• Metrics and Human Error
• KPI’s
• Human error rate
• 1st-time pass rate
• Overall Equipment Effectiveness (OEE)
• Trending /Tracking

LEARNING OBJECTIVES

• Understand human error: factors and causes
• Understand the importance: regulatory and business
• Define the process to manage human error deviations
• Learn about human error measurement
• Learn about tools for human error measurement
• Establish Key Performance Indicators
• Define and measure human error rate, cognitive load, and CAPA effectiveness
• Identify what I can do to support human reliability

WHO WILL BENEFIT

• Training managers and coordinators
• Operations
• Manufacturing
• Plant Engineering
• QA/QC staff
• Process excellence/improvement professionals
• Industrial/process engineers
• Compliance officers
• Regulatory/legislative affairs professionals
• General/corporate counsel
• Executive management

SPEAKER

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.

Ten 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, Pharmaceutical Industry Association, and International GMP Conference, among others.