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PDA Journal of Pharmaceutical Science and Technology

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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
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References

  1. 1.↵
    International Conference for Harmonisation. Quality Guideline Q9: Quality Risk Management. ICH: Geneva, 2005.
  2. 2.↵
    1. Waldron K.
    Managing Risk to the Patient: Recoding Quality Risk Management for the Pharmaceutical and Biopharmaceutical Industries. Ph.D. Thesis, Technological University Dublin, 2018.
  3. 3.↵
    1. Byrne G.
    An Investigation into Quality Risk Management Knowledge Held by Junior Quality and Manufacturing Roles in the Pharmaceutical Industry. Ph.D. Dissertation, 2019.
  4. 4.↵
    1. Haddad G.,
    2. Greene A.
    Quality Risk Management Competency Model—Case for the Need for QRM Competencies. PDA J. Pharm. Sci. Technol. 2019, 73 (4), 331–344.
    OpenUrlAbstract/FREE Full Text
  5. 5.↵
    1. Surowiecki J.
    The Wisdom of Crowds; Doubleday, 2004.
  6. 6.↵
    1. Hopf Y. M.,
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    3. Helms P. J.,
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    Linking NHS Data for Pediatric Pharmacovigilance: Results of a Delphi Survey. Res. Soc. Adm. Pharm. 2016, 12 (2), 267–280.
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    1. Adler M.,
    2. Ziglio E.
    Gazing into the Oracle: The Delphi Method and Its Application to Social Policy and Public Health; Kingsley Publishers: London, 1996.
  8. 8.↵
    1. Kittell-Limerick P.
    Perceived Barriers to Completion of the Academic Doctorate: A Delphi Study. Ed.D. Thesis, Texas A&M University-Commerce, Texas, 2005.
  9. 9.↵
    1. Rowe G.,
    2. Wright G.
    The Delphi Technique as a Forecasting Tool: Issues and Analysis. Int. J. Forecast. 1999, 15 (4), 353–375.
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  10. 10.↵
    1. Giannarou L.,
    2. Zervas E.
    Using Delphi Technique to Build Consensus in Practice. Int. Journal of Business Science and Applied Management 2014, 9 (2), 65–82.
    OpenUrl
  11. 11.↵
    1. Christie C. A.,
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    The Delphi Technique as a Method for Increasing Inclusion in the Evaluation Process. Can. J. Program Eval. 2005, 20 (1), 105–122.
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  12. 12.↵
    1. Steinar K.,
    2. Svend B.
    InterViews: Learning the Craft of Qualitative Research Interviewing; SAGE, 2009.
  13. 13.↵
    1. Hackett S.,
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    3. Phillips S.
    Exploring Consensus in Practice with Youth Who Are Sexually Abusive: Findings from a Delphi Study of Practitioner Views in the United Kingdom and the Republic of Ireland. Child Maltreat. 2006, 11 (2), 146–156.
    OpenUrlCrossRefPubMed
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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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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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