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Human error is known to be the major cause of quality and production losses in many industries. Although it is unlikely that human error will ever be totally 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. To work with these challenges it is really important to understand human behavior and the psychology of error as well as understand exactly where the systems weaknesses are, so they can be improved and/or fixed. This course offers practical approaches and models to address human performance issues in GMP related environments by using a specific methodology to correct, prevent and avoid re-occurrence of these issues.

Understand human error: factors and causesUnderstand the importance: regulatory and businessDefine the process to manage Human Error deviationsIdentify Root Causes associated to human error deviationsLearn how to measure human error rates at your siteIdentify what I can do to support human reliability

This training would provide tools that can be implemented and used after this event. This includes practical tools. We will discuss human error categories, near root causes and root causes for these events. We will discuss latest trends in human error issues in the industry.

Background on human error phenomenaImportance of human error prevention/reductionTraining and human errorFacts about human errorHuman error as the root causeWhat is human errorHow is human error controlled?Common mistakes: Memory failures, overconfidence, we believe we are above average, visual detection, vigilance effectivenessTypes of errorHuman error rates and measurementTrending and trackingPredictionCAPA effectiveness

Training managers and coordinatorsOperationsManufacturingPlant engineeringQA/QC staffProcess excellence/improvement professionalsIndustrial/process engineersCompliance officersRegulatory/legislative affairs professionalsGeneral/corporate counsel

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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