Date of Award
2015
Document Type
Dissertation
Degree Name
Doctor of Philosophy (PhD)
Department
College of Technology
Abstract
The validation of manufacturing processes is a requirement for medical device firms. Government regulations demand process validations to be executed to a certain standard before the product is released to the customers when the product conformance to specified requirements is not verifiable. However, even after validations are complete medical device companies still spend significant costs testing the products to ensure they meet the customer and regulatory requirements. This research work will investigate the rationale for process validation and its value in improving quality reducing cost and satisfying customers. The paper will research the different alternatives available for medical device manufacturers in conducting efficient and cost-effective process validations. Also included in the research is the ability to cut costs by eliminating the need to inspect products before release and after the process has been validated. The document will describe best practices available in several industries, available for use in a medical device environment. These practices will reduce the validation cycle time, maintain a validated state, and comply with increasingly demanding regulations while reducing the cost of product inspection using a process parametric release (PR) approach.
Recommended Citation
Estrada, Angel, "A Model Process To Control Quality Attributes Of A Medical Device Using Process Parameters" (2015). All-Inclusive List of Electronic Theses and Dissertations. 1826.
https://scholars.indianastate.edu/etds/1826