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How to Implement an Effective Human Error Reduction Program
- Error Reduction System
- 6 Step Implementation Process
- HES Tools
- Implementing the program
- Metrics and KPI’s
- What is Human Error
- How is Human Error controlled
- 6 step method for error prevention
- Human error rates and measurement
- Trending and tracking
- Prediction
- 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. For example; 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…” Also, the European Commission reads “Where human error is suspected or identified as the cause; this should be justified having taken care to ensure that process, procedural or system-based errors or problems have not been overlooked if present. Appropriate corrective actions and/or preventative actions (CAPAs) should be identified and taken in response to investigations. The effectiveness of such actions should be monitored and assessed, in line with Quality Risk Management principles.” We in Human Error Solutions have created the simplest and most effective human error reduction program, with 100% effectiveness when fully implemented in different organizations around the world. This valid scientific model combines qualitative and quantitative methodologies and provides practical tools that would assist your organization in achieving desired to results.
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?
This training will provide you with the steps to be able to implement a Human Error Reduction Program at your site. Include practical tools, the six steps for implementation and how to measure effectiveness to continuously improve human reliability at your site.
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.