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Research ArticleResearch

Quality Risk Management Competency Model—Case for the Need for QRM Competencies

Ghada Haddad and Anne Greene
PDA Journal of Pharmaceutical Science and Technology July 2019, 73 (4) 331-344; DOI: https://doi.org/10.5731/pdajpst.2019.009944
Ghada Haddad
1Merck & Co., 770 Sumneytown Pike, West Point, PA 19486; and
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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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References

  1. 1.↵
    International Conference for Harmonisation, Quality Guideline Q9: Quality Risk Management. ICH: Geneva, 2005.
  2. 2.↵
    International Conference for Harmonisation, Quality Guideline Q10: Pharmaceutical Quality System. ICH: Geneva, 2010.
  3. 3.↵
    1. Freidman R.
    Using QRM to Assure Lifecycle Process, Equipment, and Facility Improvement, IVT Network, 2015. www.ivtnetwork.com/article/using-qrm-assure-lifecycle-process-equipment-and-facility-improvement (accessed March 2018).
  4. 4.↵
    1. Waldron K.
    Managing Risk to the Patient: Recoding Quality Risk Management for the Pharmaceutical and Biopharmaceutical Industries. Ph.D. Thesis, Dublin Institute of Technology, 2017.
  5. 5.↵
    1. Greene A.,
    2. Calnan N.
    Has the Effort Been Commensurate with the Level of the Risk? A Review of Significant Publications Since Issue of ICH Q9, IVT Network, 2015. www.ivtnetwork.com/article/has-effort-been-commensurate-level-risk-review-significant-publications-issue-ich-q9 (accessed March day, 2019).
  6. 6.↵
    1. O'Donnell K.
    QRM in the GMP environment beyond 2020 – what should we strive for? In An Audience with International Regulators in the Manufacture of Medicines: Quality Risk Management (QRM) and Knowledge Management (KM); DIT Academic Press: Dublin, 2018.
  7. 7.↵
    ERM Academy Homepage. https://erm-academy.org/ (accessed January 9, 2019), Excerpt from About ERM.
  8. 8.↵
    1. Linstone H. A.,
    2. Turoff M.
    The Delphi Method: Techniques and Applications [Online]; Linstone H. A., Turoff M., Eds.; 2002. http://is.njit.edu/pubs/delphibook/delphibook.pdf (accessed January 9, 2019).
  9. 9.↵
    1. Frewer L. J.,
    2. Fischer A. R. H.,
    3. Wentholt M. T. A.,
    4. Marvin H. J. P.,
    5. Ooms B. W.,
    6. Coles D.,
    7. Rowe G.
    The Use of Delphi Methodology in Agrifood Policy Development: Some Lessons Learned. Technol. Forecast. Soc. Change 2011, 78 (9), 1514–1525.
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  10. 10.↵
    1. Landeta J.,
    2. Barrutia J.,
    3. Lertxundi A
    . Hybrid Delphi: A Methodology to Facilitate Contribution from Experts in Professional Contexts. Technol. Forecast. Soc. Change 2011, 78 (9), 1629–1641. http://dx.doi.org/10.1016/j.techfore.2011.03.009 (accessed Month date, year).
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  11. 11.↵
    1. Kvale S.,
    2. Brinkmann S.
    InterViews: Learning the Craft of Qualitative Research Interviewing, 2nd ed. Los Angeles, London, New Delhi, Singapore: Sage Publications, 2009.
  12. 12.↵
    International Conference for Harmonisation, Quality Guideline Q8: Pharmaceutical Development. ICH: Geneva, 2009.
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PDA Journal of Pharmaceutical Science and Technology: 73 (4)
PDA Journal of Pharmaceutical Science and Technology
Vol. 73, Issue 4
July/August 2019
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Quality Risk Management Competency Model—Case for the Need for QRM Competencies
Ghada Haddad, Anne Greene
PDA Journal of Pharmaceutical Science and Technology Jul 2019, 73 (4) 331-344; DOI: 10.5731/pdajpst.2019.009944

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Quality Risk Management Competency Model—Case for the Need for QRM Competencies
Ghada Haddad, Anne Greene
PDA Journal of Pharmaceutical Science and Technology Jul 2019, 73 (4) 331-344; DOI: 10.5731/pdajpst.2019.009944
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Keywords

  • QRM
  • ICH Q9
  • Delphi
  • Competency Models
  • ICH Q10

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