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Author: Cherisa Irene Jerez Publisher: ISBN: Category : Decision making Languages : en Pages : 212
Book Description
This qualitative, collective case study covers the experience of strategic decision making in a pharmaceutical and medical device manufacturing environment in Puerto Rico during the current economic crisis. The medical device and pharmaceutical manufacturing industry in Puerto Rico was selected because of the tax expirations targeting this specific industry and the predominance on the island this industry represents in the manufacturing environment. Despite Puerto Rico’s dominance in medical device and pharmaceutical manufacturing over the past 60 years, the current financial and government crisis poses a significant threat to executive level commitment toward maintaining operations on the island. Research questions focused on plant manager’s experiences and perspectives regarding the strategic decision-making process. Participant interviews included executives indirectly overseeing regulated facilities in Puerto Rico, four plant managers for medical device facility on the island and representatives of their direct staff, a former global operations leader for the pharmaceutical industry, and an economic representative in Puerto Rico. The interviews in conjunction with direct observation and document reviews of the four facilities provided the qualitative data used to develop a guideline of specific strategic decision making factors for future plant managers on the island and the results of the impact the external environment on the island is having on plant managers. The study concludes with recommendations for future research and application. The intent of the recommendations is to support continued manufacturing growth on the island.
Author: Cherisa Irene Jerez Publisher: ISBN: Category : Decision making Languages : en Pages : 212
Book Description
This qualitative, collective case study covers the experience of strategic decision making in a pharmaceutical and medical device manufacturing environment in Puerto Rico during the current economic crisis. The medical device and pharmaceutical manufacturing industry in Puerto Rico was selected because of the tax expirations targeting this specific industry and the predominance on the island this industry represents in the manufacturing environment. Despite Puerto Rico’s dominance in medical device and pharmaceutical manufacturing over the past 60 years, the current financial and government crisis poses a significant threat to executive level commitment toward maintaining operations on the island. Research questions focused on plant manager’s experiences and perspectives regarding the strategic decision-making process. Participant interviews included executives indirectly overseeing regulated facilities in Puerto Rico, four plant managers for medical device facility on the island and representatives of their direct staff, a former global operations leader for the pharmaceutical industry, and an economic representative in Puerto Rico. The interviews in conjunction with direct observation and document reviews of the four facilities provided the qualitative data used to develop a guideline of specific strategic decision making factors for future plant managers on the island and the results of the impact the external environment on the island is having on plant managers. The study concludes with recommendations for future research and application. The intent of the recommendations is to support continued manufacturing growth on the island.
Author: Hamid Mollah Publisher: John Wiley & Sons ISBN: 0470552344 Category : Science Languages : en Pages : 432
Book Description
Sets forth tested and proven risk management practices in drug manufacturing Risk management is essential for safe and efficient pharmaceutical and biopharmaceutical manufacturing, control, and distribution. With this book as their guide, readers involved in all facets of drug manufacturing have a single, expertly written, and organized resource to guide them through all facets of risk management and analysis. It sets forth a solid foundation in risk management concepts and then explains how these concepts are applied to drug manufacturing. Risk Management Applications in Pharmaceutical and Biopharmaceutical Manufacturing features contributions from leading international experts in risk management and drug manufacturing. These contributions reflect the latest research, practices, and industry standards as well as the authors' firsthand experience. Readers can turn to the book for: Basic foundation of risk management principles, practices, and applications Tested and proven tools and methods for managing risk in pharmaceutical and biopharmaceutical product manufacturing processes Recent FDA guidelines, EU regulations, and international standards governing the application of risk management to drug manufacturing Case studies and detailed examples demonstrating the use and results of applying risk management principles to drug product manufacturing Bibliography and extensive references leading to the literature and helpful resources in the field With its unique focus on the application of risk management to biopharmaceutical and pharmaceutical manufacturing, this book is an essential resource for pharmaceutical and process engineers as well as safety and compliance professionals involved in drug manufacturing.
Author: Laura Brown Publisher: Gower Publishing, Ltd. ISBN: 9781409418948 Category : Pharmaceutical industry Languages : en Pages : 312
Book Description
Written firmly from the perspective of the pharmaceutical industry, Laura Brown and Tony Grundy offer a guide to the tools and techniques of project management. They cover both the technical and human aspects of project management to provide clinical research, drug development and quality assurance managers or directors with a must-have reference.
Author: William Botha Publisher: Lulu.com ISBN: 1257846272 Category : Business & Economics Languages : en Pages : 136
Book Description
An incisive and value-packed insight into the practical application of the Toyota Production System (or Lean) within the biopharmaceutical, pharmaceutical and medical devices industries. Written by a gifted trainer and leader in the niche, it is filled with tricks and traps on how best to navigate the treacherous minefield of regulations while generating significant and sustained benefit to the business and the patient. The Leanership model; integrating dynamic leadership behaviors with robust control systems and effective TPS tools, is described within the covers. The author, as a result of his time as a leader, manager, trainer and consultant is able to tell relevant personal stories to illuminate the key concepts and philosophies that will enable the reader to replicate his results. Illustrated with profound quotes from world leaders and salted with a quirky sense of humor, this treasure of a work is an easy, fast read.
Author: Michael Ballot Publisher: Krieger Publishing Company ISBN: Category : Business & Economics Languages : en Pages : 322
Book Description
This text focuses on the application of management decision-making tools in the field of production and operations. It provides an analysis of strategic decision-making problems and solutions on resource allocation, forecasting, and scheduling in manufacturing, services, and inventory management.
Author: Christopher John Garvin Publisher: ISBN: Category : Languages : en Pages : 130
Book Description
The transfer of information between the drug product development and manufacturing organizations is fundamental to drug product commercialization. This information is used to characterize the product-process interaction and ensure manufacturability, and to set operating ranges at fill/finish sites. Amgen has successfully commercialized drug products for years, yet opportunities exist to improve the efficiency of process development and technology transfer, and to better align the equipment, procedures, and data collection of the groups involved in these activities. We identify improvement opportunities and develop a strategic approach, which we term the "Pilot Plant Cooperative," to enable more efficient and effective commercialization. The benefits of this strategy are assessed in three case studies: (1) a capital investment project for new laboratory filling equipment, (2) enhanced data generation in clinical manufacturing, and (3) efficiency improvements in early-stage process development studies. Based on these studies, we make specific recommendations for future work. We make additional procedural and cultural recommendations, including revising capital investment processes and implementing alignment-focused incentives and hiring practices, to ensure widespread alignment is achieved and maintained.
Author: Nadine Pahl Publisher: GRIN Verlag ISBN: 3640297644 Category : Business & Economics Languages : en Pages : 33
Book Description
Research Paper (undergraduate) from the year 2008 in the subject Business economics - Business Management, Corporate Governance, grade: 1,3, University of Applied Sciences Berlin (Master of Business Administration), course: Strategic Management, language: English, abstract: If you take the words of a former General Electrics (GE) employee to define strategy, William E. Rothschild said, “What do you want to achieve or avoid? The answers to this question are objectives. How will you go about achieving your desired results? The answer to this you can call strategy.” This statement not only highlights the need for strategy but also the need to bring strategy to fruition. Companies should not only devise strategy but also successfully clarify and execute their strategies. This means that a company has to be able to measure its strategic success. Unfortunately, company strategy is not always transparent or understood in the same way by a company’s key players. Sun Tzu, a Chinese military strategist who wrote the military treatise The Art of War, praised this aspect for strategies in war as follows: “All men can see these tactics whereby I conquer, but what none can see is the strategy out of which victory is evolved”. The Strategy Map created by Kaplan and Norton is to facilitate corporate strategy development and execution providing a missing link between strategy formulation and strategy implementation by identifying the key internal processes that drive strategic success and by aligning investment in people, technology and organizational capital for the greatest impact. The first part of the assignment describes in detail the theoretical framework of Strategy Maps. The second part uses the theory to describe and visualize the Strategy Map of General Electric Medical Systems (GEMS) – the world’s leading manufacturer of diagnostic imaging equipment. This practical approach is based on the publication of Tarun Khanna about GEMS in the Harvard Business School Press in February 2003. In conclusion, there is a brief up-to-date situation on GEMS after 2002 and some statements to the authors’ experience in creating the GEMS Strategy Map.
Author: Hyuk Kim Publisher: ISBN: Category : Pharmaceutical industry Languages : en Pages : 377
Book Description
This dissertation aims to develop a new direction, in stakeholder management terms, for the pharmaceutical industry to deal with its risks/challenges, particularly in relation to the access to essential, life-saving medicines, posed by its various stakeholders. The organizational strategy development framework of this dissertation is comprised of five phases. The first phase investigates the implications of the stakeholder management perspective for the organizational strategy development in terms of the pharmaceutical industry, examining the concepts, theories, and empirical evidences of extant studies. The second and third phases present a new analytical approach in stakeholder analysis terms, linking stakeholder analysis with organizational strategy development. The stakeholder analysis of this dissertation is performed by adopting two different types of the formal qualitative analysis - an event structure analysis and a qualitative comparative Boolean analysis -- examining 48 major global public health-related cases (which consist of 146 events) from 1987 to 2007. The stakeholder analysis examines: the key stakeholders of the pharmaceutical industry; the circumstances/conditions under which the pharmaceutical industry has put measures of stakeholder management into practice; and the types of the measures that have been adopted by the pharmaceutical industry to deal with its stakeholders in conjunction with the ability to gain access to essential, life-saving medicines. The fourth phase constructs an analogical reasoning model for the pharmaceutical industry in comparison with the food and beverage industry. In the last phase, a specific stakeholder management strategy for the pharmaceutical industry is suggested: i.e., the comprehensive, proactive, multi-stakeholder public-private partnership. This strategic option is developed based on the outcomes of the stakeholder analysis combined with those of the analogical reasoning model. The new strategic direction for the pharmaceutical industry suggested in this dissertation provides an integrated approach to the industry's strategic decision making to satisfy the multiple types of stakeholders simultaneously. It is expected that this new organizational strategy for the pharmaceutical industry can be a useful tool to realize a comprehensive win-win situation: i.e., for the pharmaceutical industry in the stakeholder management terms and for its stakeholders in the access to essential, life-saving medicine terms.
Author: Cherisa Irene Jerez
Author: Cherisa Irene Jerez
Author: Hamid Mollah
Author: Laura Brown
Author: William Botha
Author: Michael Ballot
Author: Christopher John Garvin
Author: Kimberly Ann Bates
Author: Nadine Pahl
Author: Hyuk Kim
Author: Christine M. Lontz