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Roy Welsch and Charles L. Cooney. Garber, Robert A. (Robert Andrew), 1973- Leaders for Manufacturing Program. Leaders for Manufacturing Program at MIT Massachusetts Institute of Technology. Department of Chemical Engineering Sloan School of Management 2006-11-08T16:29:53Z 2006-11-08T16:29:53Z 2004 2004 http://hdl.handle.net/1721.1/34740 56052362 Thesis (S.M.)--Massachusetts Institute of Technology, Dept. of Chemical Engineering; and, (M.B.A.)--Massachusetts Institute of Technology, Sloan School of Management; in conjunction with the Leaders for Manufacturing Program at MIT, 2004. Includes bibliographical references (leaves 84-85). This thesis investigates potential improvements to the manufacturing process through the implementation of process analytical technologies (PAT) in the heavily regulated pharmaceutical industry. The thesis focuses on the identification, prioritization, evaluation, and implementation of Process Analytical Technologies (PAT's) to solve manufacturing issues. While full implementation of a solution is not a part of this thesis, development of an implementation plan is. In parallel to executing these four stages of the project, processes and tools for the assessment of future PAT ideas are developed. The ideas developed in this thesis were tested in an industrial setting, and several case studies are included from this work. Key results are that a rigorous business evaluation of a potential project from a financial and intangible viewpoint is necessary, that PAT can improve the efficiency of a manufacturing process both at the unit operation and entire system levels, and that the organizational structure of a pharmaceutical company and the regulatory authority will have to change in order to support the integration of PAT into the manufacturing plant. Ramifications of the new technology on the organization are presented along with recommendations for organizational change to better utilize PAT. by Robert A. Garber. M.B.A. S.M. 87 leaves 3441483 bytes 3441288 bytes application/pdf application/pdf eng Massachusetts Institute of Technology M.I.T. theses are protected by copyright. They may be viewed from this source for any purpose, but reproduction or distribution in any format is prohibited without written permission. See provided URL for inquiries about permission. http://dspace.mit.edu/handle/1721.1/7582 Chemical Engineering. Sloan School of Management. Leaders for Manufacturing Program. Implementation of new technology in a regulated environment Thesis application/pdf false Publication unknown unknown <Publication xmlns="https://www.openaire.eu/cerif-profile/1.1/" id="dc4146db-5e73-4bb0-b41b-a1c7025cd8a2"> <Type xmlns="https://www.openaire.eu/cerif-profile/vocab/COAR_Publication_Types">http://purl.org/coar/resource_type/c_1843</Type> <Language>eng</Language> <Title>Implementation of new technology in a regulated environment</Title> <PublishedIn> <Publication> </Publication> </PublishedIn> <PublicationDate>2004</PublicationDate> <Authors> <Author> <DisplayName>Garber, Robert A. (Robert Andrew), 1973-</DisplayName> <Affiliation> <OrgUnit> </OrgUnit> </Affiliation> </Author> </Authors> <Editors> </Editors> <Publishers> <Publisher> <DisplayName>Massachusetts Institute of Technology</DisplayName> <OrgUnit /> </Publisher> </Publishers> <License>http://dspace.mit.edu/handle/1721.1/7582</License> <Keyword>Chemical Engineering.</Keyword> <Keyword>Sloan School of Management.</Keyword> <Keyword>Leaders for Manufacturing Program.</Keyword> <Abstract>This thesis investigates potential improvements to the manufacturing process through the implementation of process analytical technologies (PAT) in the heavily regulated pharmaceutical industry. The thesis focuses on the identification, prioritization, evaluation, and implementation of Process Analytical Technologies (PAT&apos;s) to solve manufacturing issues. While full implementation of a solution is not a part of this thesis, development of an implementation plan is. In parallel to executing these four stages of the project, processes and tools for the assessment of future PAT ideas are developed. The ideas developed in this thesis were tested in an industrial setting, and several case studies are included from this work. Key results are that a rigorous business evaluation of a potential project from a financial and intangible viewpoint is necessary, that PAT can improve the efficiency of a manufacturing process both at the unit operation and entire system levels, and that the organizational structure of a pharmaceutical company and the regulatory authority will have to change in order to support the integration of PAT into the manufacturing plant. Ramifications of the new technology on the organization are presented along with recommendations for organizational change to better utilize PAT.</Abstract> <Access xmlns="http://purl.org/coar/access_right" > </Access> </Publication>