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  - 2020 Jan 01
TA  - PDA Journal of Pharmaceutical Science and Technology
PG  - 58--72
VI  - 74
IP  - 1
4099  - http://journal.pda.org/content/74/1/58.short
4100  - http://journal.pda.org/content/74/1/58.full
SO  - PDA J Pharm Sci Technol2020 Jan 01; 74
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 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.