PT  - JOURNAL ARTICLE
AU  - Haddad, Ghada
AU  - Greene, Anne
TI  - Quality Risk Management - A Role-Based Competency Model
AID  - 10.5731/pdajpst.2019.010496
DP  - 2019 Jan 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - pdajpst.2019.010496
4099  - http://journal.pda.org/content/early/2019/09/13/pdajpst.2019.010496.short
4100  - http://journal.pda.org/content/early/2019/09/13/pdajpst.2019.010496.full
AB  - 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 QRM role-based competencies, as fundamental elements to realizing Quality Risk Management ′s benefits was conducted. The research study followed a hybrid Delphi research methodology of which elements are presented in 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.