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.

WHY SHOULD YOU ATTEND:

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

LEARNING OBJECTIVES:

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.

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

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.

REFUND POLICY:

Attendees may cancel up to two working days prior to the course start date and the refund will be processed within two working days.

We will process/provide A refund if the webinar is canceled. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinars may be canceled due to a lack of enrolment or unavoidable factors. Attendees will be notified 24 hours in advance if a cancellation occurs. Substitutions can happen anytime.

If you have any concerns about the content of the webinar and are not satisfied please contact us at care@thecomplyguide.com

Human Error Reduction Techniques in GMP manufacturing