Predictive Continuous Improvement Accelleration - Towards Performance Based Regulations and Oversight
Type
applied research project
Start Date
October 1, 2023
End Date
September 30, 2025
Acronym
PCIA
Status
ongoing
Description
This project aims to provide a unified scientific basis for quality metrics reporting, quality management maturity, and risk-based inspections, leading to an acceleration of continuous improvement adoption and providing a sound basis for a future performance-based oversight. The project is founded by the U.S. Food and Drug Administraton Broad Agency Announcement contract #75F40123C00132
Leader contributor(s)
Member contributor(s)
Venkat Venkatasubramanian
Nuala Calnan
Funder
Topic(s)
Pharmaceutical manufacturing quality
Continuous improvement
Performance based regulation
Operational excellence
Machine learning
Quality management
Method(s)
Machine learning
Case studies
Range
HSG + other universities
Principal
Department of Production Management, Institute of Technology Management, University of St.Gallen
Division(s)