Exploring the Risk-Knowledge Infinity Cycle (RKI Cycle) across the Product Lifecycle
Case studies demonstrating the link between knowledge and risk in technology transfer and commercial manufacture
Case studies demonstrating the link between knowledge and risk in technology transfer and commercial manufacture
Since the publishing of ICH Q10, Quality Risk Management (QRM) and Knowledge Management (KM) have been positioned as dual enablers to an effective Pharmaceutical Quality System. While there is broad agreement QRM and KM are highly interdependent in principle, there is recognition they are not well integrated in practice, and better integration is an opportunity to better manage risk and thus, increase patient protection.
A framework, the Risk-Knowledge Infinity Cycle (RKI Cycle), has been developed as a result of a research study carried out in conjunction with TU Dublin, to better integrate QRM and Knowledge Management which can be applied across the entire product lifecycle. Details of the framework will be explored in an upcoming ISPE webinar, and application of the Risk-Knowledge Infinity Cycle Cycle to the Commercial Manufacturing and Technology Transfer lifecycle phases will be illustrated through multiple short case studies, including examples to demonstrate the benefits of effective tacit knowledge transfer. In addition, a re-imagined PQS foundation will presented, enabled by QRM and Knowledge Management as intentionally connected and synergistic practices, as a means to reduce risk and ultimately benefit patients.
Check out the complimentary webinar Exploring the Risk-Knowledge Infinity Cycle (RKI Cycle) Across the Product Lifecycle on May 20, 2021 at 1100 ET which will also introduce the new ISPE Good Practice Guide: Knowledge Management in the Pharmaceutical Industry.
The integration of data science in biopharmaceutical manufacturing, emphasizing data quality, tech transfer efficiency, and process optimization, is the heart of this track. Led by industry experts, discussions explore leveraging digital twins, predictive analytics, and continuous improvement initiatives. Additionally, interactive roundtable discussions provide attendees with a dynamic forum...
The pharmaceutical sector stands at a crossroads of immense possibilities. We are witnessing an unprecedented surge in innovation, fueled by a remarkable partnership between industry and regulatory authorities. For example, there are initiatives fostered by the US Food and Drug Administration (US FDA) to promote innovation with programs such as CATT (CBER Advanced Technologies Team) and ETP...
Through the ISPE Foundation Professional Development Grant program, Silas Tamufor attended the 2023 ISPE Annual Meeting & Expo in October 2023. Tamufor is a PhD student and ISPE Boston Chapter member who began serving as the ISPE Boston Educational Programs Committee Chair in December 2023. He, along with 87 other students and recent graduates, attended the conference thanks to the...