Description

Get an understanding of human errors in GMP-related environments, factors and causes, and control measures to reduce the same.

Course Description

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. To work with these challenges, it is essential to understand human behavior and the psychology of error as well as understand exactly where the weaknesses of the system are so that 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 particular methodology to correct, prevent and avoid reoccurrence of these matters.

Areas Covered

• Background on Human Error Phenomena
• Human Error and GMP around the world
• Importance of Human Error Prevention/reduction
• Training and human error
• Facts about human error
• Human Error as the Root Cause
• What is Human Error
• How is Human Error controlled?
• Common mistakes: Memory failures, Overconfidence, We believe we are above average, Visual Detection, Vigilance Effectiveness.
• Types of error
• Human error rates and measurement
• Trending and tracking
• Prediction
• CAPA effectiveness

Why Should You Attend?

• Understand human error: factors and causes.
• Understand the importance: regulatory aspects and business.
• Define the process to manage Human Error deviations.
• Identify Root Causes associated with human error deviations.
• Learn how to measure human error rates at your site.
• Identify what I can do to support human reliability.

Who Will Benefit

GMP-regulated manufacturing facilities including Pharma medical devices, biologics, food and nutrition, and any other organization that has employees executing activities in which they can make mistakes. Titles that will benefit include:

• 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

About The Instructor

Ginette Collazo, Ph. D. is an Industrial-Organizational Psychologist with more than 20 years of experience specializing in Engineering Psychology and Human Reliability. These disciplines 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.

View other webinars of Ginette:

How to Write SOPs that Avoid Human Error