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Managing Knowledge and Risk – A Literature Review on the Interdependency of QRM and KM as ICH Q10 Enablers

Autor: Kevin O'Donnell, Anne Greene, Marty Lipa

Publikováno v: Level 3

Quality Risk Management (QRM) and Knowledge Management (KM) have been positioned as co-enablers to the Pharmaceutical Quality System since the 2010 issuance of ICH Q10. Yet these disciplines have remained largely distinct and disconnected in practice

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::0ebac9244ea8dc79773268b54f04a0d4
https://doi.org/10.1080/21507090.26482020mjlkoag-mkrlr

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Effective Knowledge Transfer During Biopharmaceutical Technology Transfer

Autor: Marty Lipa

Publikováno v: Journal of GXP Compliance. 23

While knowledge management (KM) has been widely applied in other sectors, the international biopharmaceutical sector has struggled with the meaningful and sustained application of effective KM practices. This is evident even though KM has been highli

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_________::f8edac4d106e55fb1a22c1cd258a8ff1
https://doi.org/10.1080/21506590.23592019mjlpkag-ektdbtt

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