2019 - Human Error Reduction and Prevention: Implementing an Effective Program and Measuring Its Efficacy

OVERVIEW
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…”
LEARNING OBJECTIVES
Human error reduction System
6-step implementation process
HES tools
Human error program implementation
Metrics and KPI’s
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. Includes practical tools, the six steps for implementation and how to measure effectiveness to continuously improve human reliability at your site.
AREAS COVERED
What is human error?
How is human error controlled?
Human error rates and measurement
Trending and tracking
Prediction
Effectiveness
WHO WILL BENEFIT?
Training managers and coordinators
Operations
Manufacturing
Plant engineering
Regulatory/legislative affairs professionals
General/corporate counsel
SPEAKER
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.
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Tel: +1-(510)-868-1040