A Case Study in Application of the Risk Knowledge Infinity Cycle
The Risk Knowledge Infinity (RKI) Cycle Framework was featured as part of the ICH-sanctioned training materials supporting the recent issuance of ICH Q9(R1) To support ICH Q9(R1) understanding and adoption, this paper presents a case study on the application of the RKI Cycle, based on an underlying...
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Published in | PDA journal of pharmaceutical science and technology Vol. 78; no. 3; p. 367 |
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Main Authors | , , , , , , |
Format | Journal Article |
Language | English |
Published |
United States
28.06.2024
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Subjects | |
Online Access | Get more information |
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Summary: | The Risk Knowledge Infinity (RKI) Cycle Framework was featured as part of the ICH-sanctioned training materials supporting the recent issuance of ICH Q9(R1)
To support ICH Q9(R1) understanding and adoption, this paper presents a case study on the application of the RKI Cycle, based on an underlying out-of-specification investigation. This case study provides a stepwise walk-through of the cycle to illustrate how key concepts within the ICH Q9(R1) revision can be achieved through better connecting quality risk management and knowledge management with a framework such as the RKI Cycle. |
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ISSN: | 1948-2124 |
DOI: | 10.5731/pdajpst.2023.012931 |