RiskSurve - Towards a Holistic Risk-based Site Surveillance
Type
applied research project
Start Date
September 1, 2021
End Date
September 30, 2023
Acronym
RiskSurve
Status
Completed
Description
This project aims to create a comprehensive Site Risk Surveillance Model using data from the four dimensions Outcome Metrics, Quality Management Maturity, Compliance History, External Signals, and their repsective context factors. The project aims at informing U.S. Food and Drug Administration's site surveillance strategy both technincally and organizationally. The project is founded by the U.S. Food and Drug Administraton Broad Agency Announcement contract #75F0121C00161
Leader contributor(s)
Member contributor(s)
Venkat Venkatasubramanian
Nuala Calnan
Funder
Topic(s)
Pharmaceutical manufacturing quality
Surveillance
Quality management
Operational excellence
Machine learning
Method(s)
Machine Learning
Case Studies
Range
HSG + other universities
Principal
Department of Production Management, Intitute of Technology Management, University of St.Gallen
Division(s)