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Article CommentaryCommentary

What Does It Really Look Like to Properly Address a “Human Error Problem” in Biopharma? The Human Performance Blue-Sky Description That Will Help Improve Industry Performance

Clifford Berry, Brian Chviruk, Danny Hernandez, Matt Beaugard, Kelly B. Stevens, Joe Polizzotto, Lene Bjerregaard and Daan Purbrick
PDA Journal of Pharmaceutical Science and Technology July 2019, 73 (4) 391-400; DOI: https://doi.org/10.5731/pdajpst.2018.009621
Clifford Berry
1Biogen, Research Triangle Park, NC;
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  • For correspondence: cliff.berry@biogen.com
Brian Chviruk
2Shire, Lexington, MA;
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Danny Hernandez
3Bayer, Berkeley, CA;
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Matt Beaugard
4Merck, West Point, PA;
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Kelly B. Stevens
5Novavax, Gaithersburg, MD;
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Joe Polizzotto
6GSK, Conshohocken, PA;
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Lene Bjerregaard
7Novo Nordisk, Copenhagen, Denmark; and
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Daan Purbrick
8Biogen, Solothurn, Switzerland
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Article Information

vol. 73 no. 4 391-400
DOI 
https://doi.org/10.5731/pdajpst.2018.009621
PubMed 
30770484

Published By 
Parenteral Drug Association (PDA)
Print ISSN 
1079-7440
Online ISSN 
1948-2124
History 
  • Published online August 6, 2019.

Article Versions

  • previous version (February 15, 2019 - 07:38).
  • You are viewing the most recent version of this article.
Copyright & Usage 
© PDA, Inc. 2019

Author Information

  1. Clifford Berry1,*,
  2. Brian Chviruk2,
  3. Danny Hernandez3,
  4. Matt Beaugard4,
  5. Kelly B. Stevens5,
  6. Joe Polizzotto6,
  7. Lene Bjerregaard7 and
  8. Daan Purbrick8
  1. 1Biogen, Research Triangle Park, NC;
  2. 2Shire, Lexington, MA;
  3. 3Bayer, Berkeley, CA;
  4. 4Merck, West Point, PA;
  5. 5Novavax, Gaithersburg, MD;
  6. 6GSK, Conshohocken, PA;
  7. 7Novo Nordisk, Copenhagen, Denmark; and
  8. 8Biogen, Solothurn, Switzerland
  1. ↵* Correspondence Author: Biogen, Research Triangle Park, NC; e-mail: cliff.berry{at}biogen.com
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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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What Does It Really Look Like to Properly Address a “Human Error Problem” in Biopharma? The Human Performance Blue-Sky Description That Will Help Improve Industry Performance
Clifford Berry, Brian Chviruk, Danny Hernandez, Matt Beaugard, Kelly B. Stevens, Joe Polizzotto, Lene Bjerregaard, Daan Purbrick
PDA Journal of Pharmaceutical Science and Technology Jul 2019, 73 (4) 391-400; DOI: 10.5731/pdajpst.2018.009621

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What Does It Really Look Like to Properly Address a “Human Error Problem” in Biopharma? The Human Performance Blue-Sky Description That Will Help Improve Industry Performance
Clifford Berry, Brian Chviruk, Danny Hernandez, Matt Beaugard, Kelly B. Stevens, Joe Polizzotto, Lene Bjerregaard, Daan Purbrick
PDA Journal of Pharmaceutical Science and Technology Jul 2019, 73 (4) 391-400; DOI: 10.5731/pdajpst.2018.009621
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    • No Absolute Victories
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Keywords

  • Human performance
  • human error
  • Human factors
  • resilience
  • reliability
  • Risk
  • design
  • Investigation
  • Root cause
  • lean
  • biotech
  • pharma
  • blue-sky

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