Date of Award


Document Type


Degree Name

Doctor of Business Administration (DBA)


Bisk College of Business

First Advisor

Alexander R. Vamosi

Second Advisor

Theodore Richardson

Third Advisor

James Glenn

Fourth Advisor

Wanfa Zhang


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.


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