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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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Article Information

vol. 74 no. 1 58-72
DOI 
https://doi.org/10.5731/pdajpst.2019.010496
PubMed 
32015153

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online February 3, 2020.

Article Versions

  • previous version (September 13, 2019 - 09:11).
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© PDA, Inc. 2020

Author Information

  1. Ghada Haddad1,2,* and
  2. Anne Greene2
  1. 1Merck & Co., 770 Sumneytown Pike, West Point, PA 19486; and
  2. 2School of Chemical and Pharmaceutical Sciences, TU Dublin–City Campus, Kevin Street, Dublin 8, Ireland
  1. ↵* Corresponding Author: Global cGMP and Compliance Organization, Merck & Co., 770 Sumneytown Pike, P.O. Box 4, West Point, PA 19486. Telephone: 215-652-3205; e-mail: ghada.haddad@merck.com
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    Pharmacy & Pharmacology 2021 8 5
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In This Issue

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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  • 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
    • Conflict of Interest Declaration
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More in this TOC Section

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  • Definition of Particle Visibility Threshold in Parenteral Drug Products—Towards Standardization of Visual Inspection Operator Qualification
  • Understanding Alignment in the Execution of Extractable Screening Studies Between Laboratories: Results of the ELSIE Lab Practices Sub-Team Industry Surveys
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Keywords

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

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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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