PT  - JOURNAL ARTICLE
AU  - Schmidt, Peer
AU  - Lipa, Martin J
AU  - Fogle, Jace
AU  - Baker, Owen
AU  - Pawlak, Timothy
AU  - McEwen, Sean
AU  - O'Donnell, Kevin
TI  - Applying Knowledge to Manage Risk - A Case Study in Application of the Risk Knowledge Infinity (RKI) Cycle
AID  - 10.5731/pdajpst.2023.012931
DP  - 2024 Jan 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - pdajpst.2023.012931
4099  - http://journal.pda.org/content/early/2024/04/25/pdajpst.2023.012931.short
4100  - http://journal.pda.org/content/early/2024/04/25/pdajpst.2023.012931.full
AB  - To support ICH Q9(R1) understanding and adoption, this paper presents a case study on the application of the RKI Cycle Framework, based on an underlying out of specification investigation. The RKI Cycle was featured as part of the ICH-sanctioned training materials supporting the recent issuance of ICH Q9(R1) Quality Risk Management. 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.