How to implement an effective Human Error Reduction Program
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Speaker : GINETTE COLLAZO
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When : Thursday, November 07, 2024
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Time : 01 : 00 PM EST
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Ginette Collazo, Ph. D., is an Industrial-Organizational Psychologist with 20 years of experience who specializes 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.
Ten years ago, Dr. Collazo established Human Error Solutions (HES), a Florida-based boutique consulting firm, where she has been able to position herself as one of the few Human Error Reduction Experts in the world. HES, led by Dr. Collazo, developed a unique methodology for human error investigations, cause determination, CA-PA development, and effectiveness that has been implemented and proven in different industries globally. This scientific method has been applied in critical quality situations and workplace accidents.
Ginette Collazo, Ph. D., is the author of Human Error: Root Cause Determination Model, published in 2008. She has also spoken at significant events like Interphex, FDAnews Annual Conference, Global Conference on Process Safety, International Conference on Applied Human Factors and Ergonomics, Pharmaceutical Industry Association, and International GMP Conference.
If you work in the GMP-regulated industry, you not only need to address human error deviations because they are an inconvenience, but you must also 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 the 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 by having taken care to ensure that process, procedural or system-based errors or problems have not been overlooked if present. Appropriate corrective 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 at Human Error Solutions have created the simplest and most effective human error reduction program, with 100% effectiveness when fully implemented in different organizations worldwide. This valid scientific model combines qualitative and quantitative methodologies and provides practical tools that would assist your organization in achieving the desired results.
Learning Objectives
- Introduction to the Human Error Reduction Program
- Understanding Human Error and Human Behavior
- Learn the 6-Step Implementation Process (step by step)
- Introduction to Human Error Solution Tools
- Implementing the program in phases
- Human Error Rate, Metrics, and KPIs
- CAPA Effectiveness
Areas Covered
- 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
- AI integration
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 the steps to implement a Human Error Reduction Program at your site. This includes practical tools, the six steps for implementation, and how to continuously measure effectiveness to improve human reliability at your site.
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$199.00
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