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PART III Industry/Academia Research on QRM/KM Relationship

机译:第三部分行业/ QRM学术界研究/公里的关系

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Among industry thought leaders that have been making a strong contribution to the quality risk management (QRM) and knowledge management (KM) dialogue is Merck KM Executive Director Marty Lipa. In conjunction with his PhD program at the Technical University of Dublin (TUD), Lipa is participating in the QRM/KM-oriented academic research going on through TUD's Pharmaceutical Regulatory Science Team (PRST) (see Part I and IPQ March 18, 2021 Part VI for more on the team and the TUD program.) At the 2021 PDA Annual Meeting held virtually in mid-March, Lipa had a chance to discuss the PRST research efforts and the insights that have been gained regarding: ? the integration of QRM and KM ? the current state of knowledge transfer during technology transfer ? methods to improve tech transfer success and process robustness through improved tacit knowledge transfer, and ? the benefits of integrating the QRM/KM concepts in reducing risk and protecting patients.
机译:在行业的思想领袖强势贡献质量风险管理(QRM)和知识管理(KM)对话是默克公里执行董事马蒂脂肪酶。都柏林大学技术(立筋),脂肪酶参与QRM / KM-oriented学术研究通过立筋的药品管理科学团队(PRST)(见我和一部分2021年3月18日,IPQ VI更多团队中的一部分和立筋计划。)几乎在3月中旬举办的会议上,脂肪酶讨论PRST研究工作和机会已经获得了关于的见解:?的集成QRM公里?知识转移的技术转让? 通过改进隐性过程的鲁棒性知识转移,?整合QRM /公里概念在减少风险和保护病人。

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