Quality Management Maturity: The Importance of Good English Writing Practices (GEWP)
English is common for most who work in a GxP-regulated industry. Though most would consider themselves firm English speakers, the truth of the matter is: most will never go beyond some standard vocabulary, and most have only little understanding of English grammar and writing style. After the Brexit, in Europe very few are English native speakers. One could likely make a case for that even English EU GxP Guidance and Drug Regulation documents suffer from this issue.
No, English is in fact not easy – good English is just not!
In company GxP documents and reports the English text often suffers from features of other languages which are unknowingly imposed on it because authors and reviewers are not native speakers.
Consequences of Poor Language Quality
Clarity and quality suffer, content is misrepresented, reports are harder to read later on, procedures are misinterpreted due to undetected ambiguity, even wrong conclusions can be the consequence of using substandard “EUnglish” instead of actual English. And when a native English speaking authority comes in for inspection (USFDA, TGA, MHRA) all of a sudden QA wonders why the authorities have such trouble seeing through the local QMS and GxP-system and find what they read rather irksome (if You need to look up “irksome” then I totally got You!). “And here we thought all is fine…”.
Tailored Training by Experts Institut
Experts Institut offers a customized and taylor-made applicational training on “Technical Editing of GxP Documents: The Relevance of Quality and Style”. This training is relevant for really all levels of GMP-/GxP-regulated organizations. The training provides theoretical elements of English language features and how they can interfere with other languages in GxP documents and reports. Important elements in English writing style are presented as well. Application of the theoretical part is then trained in inductive workshop sections to gain immediate hands-on understanding of how all this plays out in real GxP life.
Basic quality systems can make good use of this, just as well established ones can. It is a great contribution to the foundation of Pharmaceutical Quality Management Maturity.
This training is one of many reasons why Experts Institut is so unique in its work portfolio: We go beyond GMP/GxP-only – We see the big picture – We see the whole. For Your benefit.
Feel free to contact us and make an appointment to talk about how we can customize this expertise to Your need. Get ahead and in touch with us – info@expertsinstitut.de
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Vita
- COO Experts Institut
- Senior Project Consultant
- Apotheker
- Langjährige internationale Projekttätigkeit in Europa, Nordamerika, Asien, Russland
- Sachkundige Person (D – AMG, AMWHV, CH – HMG, AMBV)
- Breite Compliance Expertise im Commercial (c)GMP- und Development GMP-Bereich (IMP-GMP)
- Langjähriger Third-Party GMP-Auditor (GMP- und Non-GMP)
- GMP/GDP-Trainer seit 2010
- Quality Culture Mediator
- Trained in cross-cultural aspects of communication, contextualization, and cultural anthropology as part of an MA.MIn and DIcs enrollment at Grace College&TS, US.
