This training program will offer attendees an understanding of human errors in GMP related environments, factors and causes, and control measures to be put in place to reduce the same.
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.
Why Should You Attend:
Human error is known to be the major cause of observations from regulatory agencies, quality deviations, and production losses in many organizations. 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 in a GMP environment 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.
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.
Areas Covered in the Webinar:
- 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:
- 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
Course Provider
Ginette M Collazo,
