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Quality Risk Management - A Role-Based Competency Model.

Ghada Haddad1, Anne Greene2

  • 1Merck; ghada.haddad@merck.com.

PDA Journal of Pharmaceutical Science and Technology
|September 15, 2019
PubMed
Summary
This summary is machine-generated.

This study highlights the need for Quality Risk Management (QRM) role-based competencies. It proposes a QRM competency model based on technical and behavioral skills to enhance QRM benefits.

Keywords:
CompetencyDelphiFacilitatorICHQ9QRMSenior Management

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Area of Science:

  • Pharmaceutical Regulatory Science
  • Quality Management Systems

Background:

  • The Pharmaceutical Regulatory Science Team (PRST) at TU Dublin identified a need to enhance Quality Risk Management (QRM) benefits.
  • Realizing the full advantages of QRM requires foundational role-based competencies.

Purpose of the Study:

  • To explore the necessity of developing QRM role-based competencies.
  • To propose a QRM role-based competency model.

Main Methods:

  • A hybrid Delphi research methodology was employed.
  • The study involved a detailed questionnaire on technical and behavioral competencies.

Main Results:

  • The research gathered results from a technical and behavioral competencies questionnaire.
  • A proposed QRM role-based competency model was developed.

Conclusions:

  • Developing QRM role-based competencies is crucial for maximizing QRM benefits.
  • The proposed model provides a framework for QRM competency development.