Training Doyens is recognized by SHRM to offer Professional Development Credits (PDCs) for SHRM-CP or SHRM-SCP. This program is valid for 1 PDC for the SHRM-CP or SHRM-SCP. For more information about certification or recertification, please visit shrmcertification.org.

OVERVIEW

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 systemare 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.

WHY SHOULD YOU ATTEND

This human error prevention training would provide tools that can be implemented and used after this event. Theseinclude 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.

AREAS COVERED

• Background on Human Error Phenomena
• 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

LEARNING OBJECTIVES

• Understand human error: factors and causes.
• Understand the importance: regulatory and business.
• Define the process to manage Human Error deviations.
• Identify Root Causes associated to 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

• 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

SPEAKER

Ginette Collazo, PH.D, is a human error and human behavior expert. She has spent more than 15 years in technical training, organizational development and human reliability areas. She has worked with Bristol-Myers Squibb, Johnson & Johnson, Schering-Plough, Wyeth, and has been a consultant with major firms like Abbott, Johnson & Johnson, Perrigo, among many others. She has also implemented human error reduction programs and technology in many small and mid-sized drug and device companies. An active researcher in specialized studies related to human reliability, she is the author of numerous publications on these topics.