Human Error can not be completely avoided. We are finding that as processes become more and more improved and better controlled, often, Human Error becomes more visible. But it seems that the pharmaceutical industry still struggles to recognise and correctly addressing types of human error and regulators see human error only as a last resort. Chapter 1 of the EU-GMP Guidelines (1.4, xiv) state “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…”. Problems appearing as human error should always be explored further. Human Error is rarely the root cause of a non-conformance. But sometimes it is – and sometimes it’s a symptom of another underlying problem.
Target Group
This Webinar has been designed for upper management functions, QA personnel and other GMP functions such as GMP Compliance Managers.
Technical Requirements
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Seminar Programme as PDF