RT Journal Article
SR Electronic
T1 Quality Risk Management Competency Model- Case for the need for QRM Competencies
JF PDA Journal of Pharmaceutical Science and Technology
JO PDA J Pharm Sci Technol
FD Parenteral Drug Association (PDA)
SP pdajpst.2019.009944
DO 10.5731/pdajpst.2019.009944
A1 Haddad, Ghada
A1 Greene, Anne
YR 2019
UL http://journal.pda.org/content/early/2019/05/15/pdajpst.2019.009944.abstract
AB Abstract The Pharmaceutical Regulatory Science Team (PRST), a research team based at the Dublin Technological University (TU Dublin) in Ireland, recently conducted a Quality Risk Management (QRM) survey and a face-to-face focus group workshop to assess the level of formality of QRM roles in the biopharmaceutical sector. This was carried out as part of a research study, which identified the need for the development of QRM role-based competencies, as fundamental to realizing QRM’s benefits. The research study followed a hybrid Delphi research methodology comprised of: • Survey 1 • Focus Group Workshop • Survey 2 • Competency Model Development This paper presents the results of survey 1 and the Focus Group Workshop. Survey 1 explored the need for QRM role-based competencies and the subsequent face-to-face Focus Group Workshop built on this to propose initial standard QRM roles, with a view to confirming these, with the purpose of developing associated competencies. This paper presents the finding from Survey 1 and the Focus Group Workshop The results of the follow-on research activities will be presented in a subsequent paper entitled: Quality Risk Management Competency Model -Developing Competencies and Presenting the Model