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Research ArticleResearch

Quality Risk Management—A Role-Based Competency Model

Ghada Haddad and Anne Greene
PDA Journal of Pharmaceutical Science and Technology January 2020, 74 (1) 58-72; DOI: https://doi.org/10.5731/pdajpst.2019.010496
Ghada Haddad
1Merck & Co., 770 Sumneytown Pike, West Point, PA 19486; and
2School of Chemical and Pharmaceutical Sciences, TU Dublin–City Campus, Kevin Street, Dublin 8, Ireland
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  • For correspondence: ghada.haddad@merck.com
Anne Greene
2School of Chemical and Pharmaceutical Sciences, TU Dublin–City Campus, Kevin Street, Dublin 8, Ireland
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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.

  • Competency
  • Delphi
  • Facilitator
  • ICHQ9
  • QRM
  • Senior Management

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    PDA Journal of Pharmaceutical Science and Technology: 74 (1)
    PDA Journal of Pharmaceutical Science and Technology
    Vol. 74, Issue 1
    January/February 2020
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    Quality Risk Management—A Role-Based Competency Model
    Ghada Haddad, Anne Greene
    PDA Journal of Pharmaceutical Science and Technology Jan 2020, 74 (1) 58-72; DOI: 10.5731/pdajpst.2019.010496

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    Quality Risk Management—A Role-Based Competency Model
    Ghada Haddad, Anne Greene
    PDA Journal of Pharmaceutical Science and Technology Jan 2020, 74 (1) 58-72; DOI: 10.5731/pdajpst.2019.010496
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    • Article
      • Abstract
      • 1. Introduction
      • 2. Delphi Research Methodology
      • 3. Brief Overview of Questionnaire
      • 4. Data Analysis Methodology
      • 5. Results and Discussion
      • 6. QRM Role-Based Competency Model
      • 7. Examples of Role-Based Technical and Behavioral Competencies
      • 8. Implementation Strategy
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    Keywords

    • Competency
    • Delphi
    • Facilitator
    • ICHQ9
    • QRM
    • Senior Management

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