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Validity : 18th Nov'24 to 28th Nov'24
Unraveling Mistakes: A Comprehensive Course on Human Error Investigation
- Human Error as the Root Cause
- What is Human Error
- How is Human Error controlled?
- Root Cause Determination
- Types of error
- Human error and training: when and where
- Human error rates and measurement
- Trending and tracking
- Prediction
- CAPA effectiveness
Overview of the webinar
If you work in the GMP regulated industry you not only need to address human error deviations because they are an inconvenience, you must do it because the regulation requires it. The CFR - Code of Federal Regulations Title 21 Subpart B_Organization and Personnel Sec. 211.22 talks about the “Responsibilities of quality control unit.” and it states that “(a) There shall be a quality control unit that shall have the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging material, labeling, and drug products, and the authority to review production records to assure that no errors have occurred or, if errors have occurred, that they have been fully investigated…” That being said Human Error is NOT a root cause. Human errors start at the design stage. From procedures, training, and workplace environment many variables that affect human behavior CAN be controlled 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 implementing a process exclusively dedicated to investigating and “fixing” these problems. 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.
Who should attend?
- 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
Why should you attend?
We need to be able to explain human behavior. Did the human fail because process weaknesses set them for failure? Do procedures provide for all information and clearly indicate critical steps and warning or cautions associated with steps? Do systems work for manufacturing or it the other way around? These are all tough questions to ask, but most importantly answer. 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.
- Understand the psychology of error
- Regulatory requirements in GMP environments for managing human performance deviations.
- Root Cause Analysis and Investigation
- Root Cause Determination Tool
- Establish the Human Error Rate at your site
- Implementing the program
- Metrics and KPI’s
Faculty - Dr.Ginette Collazo
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. A GMP expert also has a Keynote Speaker at significant events worldwide.
Ginette Collazo, Ph. D., is the author of several books, “Including 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.