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Quality Risk Management-A Role-Based Competency Model.

Ghada Haddad1,2, Anne Greene2

  • 1Merck & Co., 770 Sumneytown Pike, West Point, PA 19486; and ghada.haddad@merck.com.

PDA Journal of Pharmaceutical Science and Technology
|February 5, 2020
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Summary
This summary is machine-generated.

This study highlights the need for defined quality risk management (QRM) competencies. It proposes a role-based competency model to enhance QRM benefits in pharmaceutical regulatory science.

Keywords:
CompetencyDelphiFacilitatorICHQ9QRMSenior Management

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Area of Science:

  • Pharmaceutical Regulatory Science
  • Quality Risk Management

Background:

  • The Pharmaceutical Regulatory Science Team (PRST) at Technological University Dublin (TU Dublin) identified a need for structured quality risk management (QRM) competencies.
  • Realizing the full benefits of QRM requires foundational role-based competencies.

Purpose of the Study:

  • To explore the necessity of developing role-based competencies for effective quality risk management.
  • To propose a comprehensive QRM role-based competency model.

Main Methods:

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

Main Results:

  • The research identified key technical and behavioral competencies essential for QRM roles.
  • A proposed QRM role-based competency model was developed based on the findings.

Conclusions:

  • Establishing defined QRM competencies is crucial for maximizing the advantages of quality risk management.
  • The proposed model provides a framework for developing and implementing QRM competencies in the pharmaceutical industry.