Quality Risk Management—A Role-Based Competency Model

Ghada Haddad; Anne Greene

doi:10.5731/pdajpst.2019.10496

Abstract

In collaboration with the Pharmaceutical Regulatory Science Team (PRST), a research team based at the Technological University Dublin (TU Dublin) in Ireland, a research study exploring the need for developing quality risk management (QRM) role-based competencies as fundamental elements to realizing QRM's benefits was conducted. The research study followed a hybrid Delphi research methodology of which elements are presented in the paper titled “Quality Risk Management Competency Model–Case for the need for QRM Competencies.” This paper presents the second part of the Delphi research methodology, focusing on the results of a detailed technical and behavioral competencies questionnaire and a proposed QRM role-based competency model.

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