ARTICLES BY GRANT MORDUE
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The 8-Step Checklist To Write Effective Investigation Reports7/16/2021
It’s always best to prevent the need to investigate a non-compliance, but if you experience a non-compliance, it’s necessary to quickly and effectively perform an investigation. The investigation report needs to be clearly understandable to anyone reviewing the report, and hopefully you'll also learn enough to make sure the non-compliance doesn't recur.
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How To Generate The Right Input Data For An Effective Quality Management Review System9/21/2020
In this part two in a series about demonstrating CGMP compliance during inspections by establishing a successful quality culture and related systems, we turn our attention to the input data for an effective quality management review.
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Closing The Perception-Vs.-Reality Gap In CGMP Quality Culture And Compliance9/16/2020
This article is the first in a two-part series on how to demonstrate a high level of current good manufacturing practice (CGMP) compliance during inspections by implementing a strong quality culture; driving the open, transparent communication of risks; and establishing effective quality risk management and quality management review.