“Holistic Risk-based Site Surveillance – A Data-based Approach to Site Quality Risk Identification and Assessment in the Pharmaceutical Industry”

Authors

Matteo Bernasconi, Institute of Technology Management, University of St. Gallen, SwitzerlandFollow
Thomas Friedli, Institute of Technology Management, University of St. Gallen, SwitzerlandFollow
Nuala Calnan (editor), Technological University DublinFollow

Abstract

Effective quality risk management is fundamental in guaranteeing the development and manufacture of high-quality drugs, reducing drug shortages, and avoiding harm to patients’ health. The ability to accurately assess the actual risk environment, predict potential product quality or supply disruption issues and act to eliminate, prevent, reduce or mitigate them is key to improvements in quality management maturity. This paper illustrates a just-launched research project aimed at developing a comprehensive framework for how to assess and predict risks by leveraging a range of diverse factors.

Recommended Citation

Bernasconi, Matteo; Friedli, Thomas; and Calnan (editor), Nuala (2021) "“Holistic Risk-based Site Surveillance – A Data-based Approach to Site Quality Risk Identification and Assessment in the Pharmaceutical Industry”," Level 3: Vol. 16: Iss. 1, Article 8.
Available at: https://arrow.tudublin.ie/level3/vol16/iss1/8

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