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
Anne Greene
2School of Chemical and Pharmaceutical Sciences, TU Dublin–City Campus, Kevin Street, Dublin 8, Ireland

References
- 1.↵International Conference for Harmonisation. Quality Guideline Q9: Quality Risk Management. ICH: Geneva, 2005.
- 2.↵
- Waldron K.
- 3.↵
- Byrne G.
- 4.↵
- Haddad G.,
- Greene A.
- 5.↵
- Surowiecki J.
- 6.↵
- Hopf Y. M.,
- Francis J.,
- Helms P. J.,
- Haughney J.,
- Bond C.
- 7.↵
- Adler M.,
- Ziglio E.
- 8.↵
- Kittell-Limerick P.
- 9.↵
- Rowe G.,
- Wright G.
- 10.↵
- Giannarou L.,
- Zervas E.
- 11.↵
- Christie C. A.,
- Barela E.
- 12.↵
- Steinar K.,
- Svend B.
- 13.↵
In This Issue
PDA Journal of Pharmaceutical Science and Technology
Vol. 74, Issue 1
January/February 2020
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
Jump to section
- 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
- Footnotes
- References
- Figures & Data
- References
- Info & Metrics
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