An Exploratory Study Of The Impact Of Quality Management Practices On Data Integrity FDA-483 Observations Received By Pharmaceutical Manufacturers In Florida

Author

Sarah Mary Christie, Florida Institute of Technology

Date of Award

7-2023

Document Type

Dissertation

Degree Name

Doctor of Business Administration (DBA)

Department

Bisk College of Business

First Advisor

Alexander R. Vamosi

Second Advisor

Theodore Richardson

Third Advisor

James Glenn

Fourth Advisor

Wanfa Zhang

Abstract

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.

Comments

Copyright held by author

Recommended Citation

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.
https://repository.fit.edu/etd/1312