Hear By Dr. Ginette Collazo - a 15 year veteran of helping drug, biologic and device firms reduce manufacturing errors.
Understand human error: factors and causes.
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 One Should 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.
Key Learning Objectives of the Topic:
- 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
- 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
Dr Ginette M. Collazo,
Owner - Industrial/Organizational Psychologist ,
Ginette M. Collazo, Inc.
Dr. Ginette M. Collazo obtained her PhD in Industrial/Organizational Psychology from the Interamerican University of Puerto Rico. Ginette has over 15 years of experience in the pharmaceutical industry with the Technical Training, Organizational Development and Human Reliability fields.
Her work experience is from Bristol Myers Squibb, Johnson & Johnson, Schering Plough and Wyeth, holds specialized studies in Human Reliability, and has authored various publications on this topic. Her most recent publication is "Error Humano: C4c06 Modelo de Determinación de Raiz Causa", a book that describes success factors that reduce human errors. Having implemented Human Reliability programs in various industries, she understands firsthand what works and what doesn’t when trying to change a culture from an error tolerant environment to an error free learning organization.
Currently she is the president of Ginette M. Collazo, Inc. a firm that works with organizations to improve productivity by helping them identify and implement innovative strategies that will warrant that business objectives and results are met and exceeded. GMC, Inc. specializes, also, in Human Error reduction allowing organizations to achieve savings and reduce/avoid unnecessary costs associated with people’s mistakes.
Ginette’s clients all over the world including Germany, Argentina, USA, Trinidad Tobago, Dominican Republic, Singapore, Europe, and more. She has been a guest speaker about these topics in several professional conferences including American Institute for Chemical Engineers Global conference, Center for Chemical and Process Safety, American Society for Quality, California State Lands Commission Prevention First 2010 conference, Interphex PR and NY, FDAnews, among others.
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
- Pharmaceutical Industry
- Although not presently stated in the draft , the same guide could be used by FDA Regulated Industries personnel.