By Amnon Eylath, Broad Spectrum GXP Consulting

Published in: Pharmaceutical Online Newsletter

Published on: October 6, 2023

In the biopharma industry, “human error” is often selected to describe a deviation for which the immediate apparent cause was the behavior, which could be through action or inaction, of the person(s) performing a task or process. Too often, “retraining” is selected as the preventive action that, hopefully, will prevent that person or persons from repeating the deviation. As anyone with significant experience working in the GMP domain knows, repetition of training may be effective for straightforward and simple work, but not for complex tasks or for activities that require the application of self-awareness, critical thinking, and real-time judgment, all of which are critical in situations that are not nominal to the process.

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