Stephan Köhler
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Last Name
Köhler
First name
Stephan
Email
stephan.koehler@unisg.ch
Phone
+41 71 224 7271

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Publication

Operational Excellence in Pharmaceutical Quality Control Labs: Driver of an Effective Quality System

2019-02-21 , Köhler, Stephan , Friedli, Thomas , Basu, Prabir

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Publication

FDA Quality Metrics Research Final Report Year 2

2018-11 , Friedli, Thomas , Köhler, Stephan , Buess, Paul , Eich, Steffen , Basu, Prabir , Calnan, Nuala

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Publication

Effektivitätssteigerung des Qualitätssystems durch Förderung der Qualitätskultur

2017-12 , Friedli, Thomas , Buess, Paul , Köhler, Stephan , Mänder, Christian

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Publication

The Impact of Quality Culture on Operational Performance - An Empirical Study from the Pharmaceutical Industry

2018-07-20 , Friedli, Thomas , Buess, Paul , Köhler, Stephan , Chen, Cylia , Mendivil, Steve , Baker, Denyse

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Publication

FDA Quality Metrics Research Final Report

2017-11 , Friedli, Thomas , Köhler, Stephan , Buess, Paul , Basu, Prabir , Calnan, Nuala

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Publication

Cultural Excellence as the Foundation for Effectiveness of the Pharmaceutical Quality System

2017-08 , Friedli, Thomas , Köhler, Stephan , Buess, Paul

In pharmaceutical companies, it is universally understood that a robust Pharmaceutical Quality System (PQS) provides key elements of assurance and oversight for pharmaceutical manufacturing and quality control laboratory processes. However, despite recent advances in the manufacturing sector, quality issues remain a frequent occurrence. The research shows that a high degree of PQS Effectiveness is accompanied with a high level of Cultural Excellence.

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Publication

21c Quality Management in the Pharmaceutical Industry

2018 , Friedli, Thomas , Basu, Prabir K. , Mänder, Christian , Calnan, Nuala , Biehl, Sebastian , Braun, Matthias , Buess, Paul , Köhler, Stephan , Lamba, Sanjit S. , Lehmann, Bernd , Lembke, Nikolaus , Lima, Jose Mario , Lupo, Marco , Moloney, Conor , Ponce, Nicolas , Reddy, Madan M. , Schneider, Uli , Friedli, Thomas , Basu, Prabir K. , Mänder, Christian , Calnan, Nuala

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Publication

HSG-Institut unterstützt Industrie und FDA bei Sicherstellung der Arzneiversorgung und Prävention von Qualitätsproblemen

2019 , Friedli, Thomas , Eich, Steffen , Köhler, Stephan

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Publication

FDA Quality Metrics Research - 3rd Year Report

2019-12 , Friedli, Thomas , Köhler, Stephan , Eich, Steffen , Macuvele, Lars-Julian , Ritz, Marten , Calnan, Nuala , Basu, Prabir

This report presents the findings from three years of Quality Metrics Research and builds on seminal outcomes from earlier operations and quality management research, e.g. Voss et al. (Voss, Blackmon, Hanson, & Oak, 1995), Ferdows and De Meyer (Ferdows & De Meyer, 1990), Deming (Deming, 1986). The work undertaken in year 3 has deepened the insights and enhanced the models developed in the first two years of Quality Metrics Research by the University of St.Gallen (Friedli, Köhler, Buess, Basu, & Calnan, 2017, 2018). The following main results are highlighted below and are further described in more detail in this report in the relevant chapters noted.

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