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 the 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.
Join this session by expert speaker Ginette Collazo, where she will discuss how to implement an effective investigation program in order to reduce human error.
Session Highlights:
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
Error Reduction System
6 Step Implementation Process
HES Tools
Implementing the program
Metrics and KPI’s
Why You Should 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.
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
*You may ask your Question directly to our expert during the Q&A session.
** You can buy On-Demand and view it as per your convenience.
Ginette Collazo
Ginette Collazo, Ph. D. is an Industrial-Organizational Psychologist with 20 years of experience that specializes in Engineering Psychology and Human Reliability, disciplines that 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.
Nine years ago, Dr. Collazo established Human Error Solutions, LLC (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 amongst different industries globally. This scientific method has been applied in critical quality situations and workplace accidents.
Ginette Collazo, Ph. D. is the author of the book Human Error: Root Cause Determination Model, published in 2008. She is also a speaker at significant events like Interphex, FDAnews Annual Conference, Global Conference on Process Safety, International Conference on Applied Human Factors and Ergonomics, and of course, Pharmaceutical Industry Association.