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Full-Text Articles in Biotechnology
Advancing Competency In Managing Risk And Knowledge: Steps Toward Operationalisation Of The Risk-Knowledge Infinity Cycle (Rki Cycle) - Part 1: Improving Effectiveness Of Risk-Based Decision Making (Rbdm), Martin Lipa, Paige Kane, Anne Green
Advancing Competency In Managing Risk And Knowledge: Steps Toward Operationalisation Of The Risk-Knowledge Infinity Cycle (Rki Cycle) - Part 1: Improving Effectiveness Of Risk-Based Decision Making (Rbdm), Martin Lipa, Paige Kane, Anne Green
Articles
To date, literature on the Risk-Knowledge Infinity Cycle (RKI Cycle) has mainly been theoretical. This paper series intent is to focus on the operationalisation of the RKI Cycle by describing a series of steps – the “How to” – for RKI Cycle deployment, to help move the RKI Cycle from theory to practice. The first paper in this series focuses on how the RKI Cycle can support effective Risk-Based Decision Making (RBDM).
Effective Knowledge Transfer During Biopharmaceutical Technology Transfer - How Well Do We Do It?, Martin J. Lipa, Paige Kane, Anne Greene
Effective Knowledge Transfer During Biopharmaceutical Technology Transfer - How Well Do We Do It?, Martin J. Lipa, Paige Kane, Anne Greene
Articles
Author’s Note: This is the author’s submitted manuscript which has subsequently been published in the Journal of Validation Technology (www.ivtnetwork.com, Volume 25, Issue 4 – August 2019).
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 highlighted in regulatory guidance for over 10 years, and the positive business impact of KM is well recognized in other sectors. This paper focuses on the topic of KM as applied to biopharmaceutical technology transfer, introducing …