Date of Award
Doctor of Business Administration (DBA)
Bisk College of Business
Alexander R. Vamosi
Quality management systems and regulatory compliance have been studied in academic and practitioner settings (Andersson et al., 2006; Beattie & Sohal, 1999; Berrouiguet, 2013; McDowall & Ratcliff, 2016; Unger, 2019; Wechsler, 2019). While research has been performed on both topics independently, there has not been a definitive analysis of the relationship between quality management practices and regulatory compliance, especially in an FDA-regulated manufacturing environment. This research study attempts to link quality management practices and regulatory compliance and provides valuable insights for working managers on the practitioner level.
Christie, Sarah Mary, "An Exploratory Study Of The Impact Of Quality Management Practices On Data Integrity FDA-483 Observations Received By Pharmaceutical Manufacturers In Florida" (2023). Theses and Dissertations. 1312.