Human Error Reduction in GMP Related Environments

Human error is a major cause of quality and production losses in many industries. It may never be eliminated entirely, but many human performance problems can be prevented. This 60-minute webinar on human error reduction in GMP environments offers practical approaches and models, with a specific methodology to correct and prevent errors and stop them from recurring.

Errors often start at the design stage. Procedures, training and the workplace environment all shape behavior and can be adjusted to make errors less likely. Doing that well requires understanding human behavior, the psychology of error and exactly where the system is weak.

You'll cover error categories, near root causes and root causes, error rates and measurement, trending, prediction, CAPA effectiveness and current trends in human error issues.

• Explain the factors and causes of human error
• Describe why human error matters for regulatory and business performance
• Define a process to manage human error deviations
• Identify root causes of human error deviations
• Measure human error rates at your site
• Identify what you can do to support human reliability

• Background on human error phenomena
• Why human error prevention and reduction matter
• Training and human error
• Facts about human error
• When human error is the root cause
• What human error is
• How human error is controlled
• Common mistakes: memory failures, overconfidence, believing we are above average, visual detection and vigilance
• Types of error
• Human error rates and measurement
• Trending and tracking
• Prediction
• CAPA effectiveness

Blaming individuals rarely stops human error from happening again. This training gives you practical tools you can put to use after the event to manage human error deviations and support reliability at your site.

It suits training managers and coordinators, operations, manufacturing and plant engineering staff, QA/QC, process improvement and industrial engineers, compliance and regulatory professionals, and corporate counsel.

• 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

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.