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 latest trends in human error issues in the industry.
- 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
- CAPA Effectiveness
- 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
- Plant Engineering
- QA/QC staff
- Process Excellence/Improvement Professionals
- Industrial/Process Engineers
- Compliance Officers
- Regulatory/Legislative Affairs Professionals
- General/Corporate Counsel
Industries who can attend
This 180 -minute online course is intended for professionals in the Medical Device, Biotechnology,Pharmaceutical Industry. Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.
Faculty Ginette M. Collazo
DR. Ginette M. Collazo has spent more than 15 years in technical training, organizational development and human reliability. She has worked with Bristol-Myers Squibb, Johnson & Johnson, Schering-Plough, Wyeth and Medtronic, many more 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.