10 Pharmaceutical Technology REGULATORY SOURCEBOOK DECEMBER 2019 P h a r mTe c h . c o m
tools (e.g., by creating small pilot projects to dem-
onstrate the benefit of a specific technology). With
artificial intelligence, for instance, a lot of the cod-
ing needed to build solutions is open source and
doesn't cost a lot," she says.
Overall, training will be crucial to building a
culture of quality. "People come to work wanting
to do the right thing. It is all how managers send
the message down and how they create an envi-
ronment of trust. That is really the bottom line,"
she says.
References
1. FDA, Quality Metrics for Drug Manufacturing, fda.gov, October
7, 2018, www.fda.gov/drugs/pharmaceutical-quality-resources/
quality-metrics-drug-manufacturing
2. A. Harrison and S. Schniepp, PharmTech 39(9) pp. 22-25 (2015).
3. S. Caramela, "The Management Theory of Peter Drucker,"
business.com, Feb. 27, 2018, www.business.com/articles/man-
agement-theory-of-peter-drucker/
4. T. Friedli et al, PDA Journal 72(5), pp. 531-542, September 2018
5. A. Srinavasan and B. Karey, "Creating a Culture of Quality,"
hbr.org, April 2014, https://hbr.org/2014/04/creating-a-culture-
of-quality.
6. M. Kimes, "Why J&J's Headache Won't Go Away," fortune.com,
August 19, 2010, https://archive.fortune.com/2010/08/18/news/
companies/jnj_drug_recalls.fortune/index.htm
7. W. Adis, "McNeil, a J&J Subsidiary FDA Case Study," Commu-
nications of the International Information Management Associa-
tion (IIMA), 14 (3), Article 2, https://scholarworks.lib.csusb.
edu/cgi/viewcontent.cgi?referer=https://www.google.com/&htt
psredir=1&article=1359&context=ciima
8. E. Palmer, "Mylan Fired Workers at Agila Plant," fiercepharma.
com, June 27, 2016.
9. FDA, Warning Letter, Strides Pharma Science Ltd., fda.gov, July
1, 2019, www.fda.gov/inspections-compliance-enforcement-
and-criminal-investigations/warning-letters/strides-pharma-
science-limited-576722-07012019
10. Shanley, A., Pharm. Tech. 2016 Supplement Issue 2 pp s40-s44,
www.pharmtech.com/offshore-supplier-quality-trust-
verify?pageID=2
11. Harvard Business Review ideacast, Creating Psychological
Safety in the Workplace, an Interview with Amy Edmonson,
hbr.org, January 22, 2019, https://hbr.org/ideacast/2019/01/cre-
ating-psychological-safety-in-the-workplace
12. J. Macher, "Business Case for Quality, a presentation at the
Pharma Quality Systems," ICH Q10 Conference, October 4-6,
2011, www.fda.gov/media/82992/download
13. R. Kegan, In Over Our Heads: The Mental Demands of Mod-
ern Life (Harvard University Press, 1994).
PT
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