Implementation of new technology in a regulated environment

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.

Bibliographic Details
Main Author: Garber, Robert A. (Robert Andrew), 1973-
Other Authors: Roy Welsch and Charles L. Cooney.
Format: Thesis
Language:eng
Published: Massachusetts Institute of Technology 2006
Subjects:
Online Access:http://hdl.handle.net/1721.1/34740
_version_ 1811094128356753408
author Garber, Robert A. (Robert Andrew), 1973-
author2 Roy Welsch and Charles L. Cooney.
author_facet Roy Welsch and Charles L. Cooney.
Garber, Robert A. (Robert Andrew), 1973-
author_sort Garber, Robert A. (Robert Andrew), 1973-
collection MIT
description 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.
first_indexed 2024-09-23T15:55:31Z
format Thesis
id mit-1721.1/34740
institution Massachusetts Institute of Technology
language eng
last_indexed 2024-09-23T15:55:31Z
publishDate 2006
publisher Massachusetts Institute of Technology
record_format dspace
spelling mit-1721.1/347402022-01-28T19:51:16Z Implementation of new technology in a regulated environment Garber, Robert A. (Robert Andrew), 1973- Roy Welsch and Charles L. Cooney. Leaders for Manufacturing Program. Leaders for Manufacturing Program at MIT Massachusetts Institute of Technology. Department of Chemical Engineering Sloan School of Management Chemical Engineering. Sloan School of Management. Leaders for Manufacturing Program. 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. 2006-11-08T16:29:53Z 2006-11-08T16:29:53Z 2004 2004 Thesis http://hdl.handle.net/1721.1/34740 56052362 eng 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 87 leaves 3441483 bytes 3441288 bytes application/pdf application/pdf application/pdf Massachusetts Institute of Technology
spellingShingle Chemical Engineering.
Sloan School of Management.
Leaders for Manufacturing Program.
Garber, Robert A. (Robert Andrew), 1973-
Implementation of new technology in a regulated environment
title Implementation of new technology in a regulated environment
title_full Implementation of new technology in a regulated environment
title_fullStr Implementation of new technology in a regulated environment
title_full_unstemmed Implementation of new technology in a regulated environment
title_short Implementation of new technology in a regulated environment
title_sort implementation of new technology in a regulated environment
topic Chemical Engineering.
Sloan School of Management.
Leaders for Manufacturing Program.
url http://hdl.handle.net/1721.1/34740
work_keys_str_mv AT garberrobertarobertandrew1973 implementationofnewtechnologyinaregulatedenvironment