Human Error Investigations, Root Cause Determination and CAPA Effectiveness
Speaker: Ginette Collazo, Ph. D
Speaker Designation: CEO, Human Error Solutions
Speaker: Ginette Collazo, Ph. D
Speaker Designation: CEO, Human Error Solutions
Many variables, from procedures to training to workplace environment, affect human behavior. You need to understand human behavior and the psychology of error in order to implement a process dedicated to investigating and fixing human errors.
This training program will offer attendees an understanding of human error, its factors, and its causes. The program will also identify the regulatory and business importance of human error prevention and define the process of managing human error deviations.
Human error is known to be the major cause of quality and production losses in many industries. 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, it is really important to understand human behavior and the psychology of error as well as understand exactly where the weaknesses of the system are, so they can be improved and/or fixed. This course will offer practical approaches to address human performance issues in GMP-related environments by using a specific methodology to correct, prevent, and avoid re-occurrence of these issues.
Human error investigations and CAPA are essential elements in an organization's risk management framework. By focusing on thorough root cause analysis and implementing effective CAPA, organizations can significantly reduce the incidence of human error and enhance operational efficiency. The key to long-term success lies in continuously monitoring CAPA effectiveness and being proactive in addressing not just immediate issues, but also the broader system that enables human errors.
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.
In 2009, Dr. Collazo established Human Error Solutions (HES), a US-based boutique consulting firm. She has positioned herself as one of the few Human Error Reduction Experts worldwide. HES, led by Dr. Collazo, developed a unique methodology for human error investigations, cause determination, CA-PA development, and effectiveness implemented and proven amongst different industries globally. Furthermore, this scientific method has been applied in critical quality situations and workplace accidents. As a GMP expert also has a Keynote Speaker at significant events around the world.
Ginette Collazo, Ph. D., is the author of several books, “Human Error: Root Cause Determination Model” and “Mission Matters: World Leading Entrepreneurs Reveal their Top Tips to Success.” Also, she is the host of The Power of Why Podcast. A show about human behavior in the workplace and critical thinking.
FDAnews has called her a “veteran of helping drug, biologic and device firms reduce manufacturing errors,” and the Caribbean Business describes her as “ the missing link in modern business.” Today her Error Reduction System has been implemented in all types of industries worldwide.