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Author: Bikash Chatterjee
Publisher: CRC Press
ISBN: 1317180100
Category : Business & Economics
Languages : en
Pages : 171
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Book Description
Bikash Chatterjee emphasizes the criticality of applying the principles of Lean and Six Sigma within the paradigm of the drug development process. His guide to operational excellence in the pharmaceutical and biotech industries is a focused summary of the application of Lean Six Sigma theory to the regulated life sciences. From molecule discovery to the application of PAT Applying Lean Six Sigma in the Pharmaceutical Industry will highlight the importance of framing these initiatives within the key deliverables of drug development manufacturing and quality. Challenging conventional wisdom the author offers a quality and efficiency perspective as a foundation for the principles of Quality by Design, PAT and the new philosophies underlying Process Validation. Each chapter includes discussion around the considerations for applying Lean manufacturing and Six Sigma principles and their tools, culminating in a case study to illustrate the application. The book is organized to reflect the major work centers involved in the drug development lifecycle. Each chapter is stand-alone but together they illustrate the necessary synergy between Lean, Six Sigma and compliance sensibilities required to be successful in the pharmaceutical industry. These design, manufacturing and management techniques are not without their challenges. Bikash Chatterjee's book offers the roadmap for an industry that is struggling to reinvent many of its development and business processes.
Author: Bikash Chatterjee
Publisher: CRC Press
ISBN: 1317180100
Category : Business & Economics
Languages : en
Pages : 171
Get Book Here
Book Description
Bikash Chatterjee emphasizes the criticality of applying the principles of Lean and Six Sigma within the paradigm of the drug development process. His guide to operational excellence in the pharmaceutical and biotech industries is a focused summary of the application of Lean Six Sigma theory to the regulated life sciences. From molecule discovery to the application of PAT Applying Lean Six Sigma in the Pharmaceutical Industry will highlight the importance of framing these initiatives within the key deliverables of drug development manufacturing and quality. Challenging conventional wisdom the author offers a quality and efficiency perspective as a foundation for the principles of Quality by Design, PAT and the new philosophies underlying Process Validation. Each chapter includes discussion around the considerations for applying Lean manufacturing and Six Sigma principles and their tools, culminating in a case study to illustrate the application. The book is organized to reflect the major work centers involved in the drug development lifecycle. Each chapter is stand-alone but together they illustrate the necessary synergy between Lean, Six Sigma and compliance sensibilities required to be successful in the pharmaceutical industry. These design, manufacturing and management techniques are not without their challenges. Bikash Chatterjee's book offers the roadmap for an industry that is struggling to reinvent many of its development and business processes.
Author: Brian K. Nunnally
Publisher: CRC Press
ISBN: 1420054406
Category : Mathematics
Languages : en
Pages : 222
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Book Description
Six Sigma in the Pharmaceutical Industry is the first book to introduce the fundamentals of Six Sigma, examine control chart theory and practice, and explain the concept of variation management and reduction applied specifically to the pharmaceutical industry. The first half lays out a conceptual framework for understanding variation, while the second half introduces control chart theory and practice. Using case studies and statistics, the book illustrates the concepts and explains their application to actual workplace improvements. Providing the basis for a complete operating philosophy, this book focuses on core concepts and their implementation to improve the existing products and processes in the pharmaceutical industry.
Author: Souraj Salah
Publisher: Springer
ISBN: 3319990349
Category : Technology & Engineering
Languages : en
Pages : 247
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Book Description
This book offers a comprehensive guide to implementing a company-wide management system (CWMS), utilising up-to-date methodologies of lean-six sigma in order to achieve high levels of business excellence. It builds the foundation for quality and continuous improvement, which can be implemented in any organization. The book begins with an introduction to and an overview of CWMSs, and reviews the existing literature on various management systems. It then discusses the integration and implementation of lean-six sigma in supply chain management. The integration approach presented highlights the link between the existing management systems and shows how continuous improvement methodologies are incorporated. The book then examines the components of CWMS, comparing them to other systems. It also explores Kano-based six sigma and concludes with further recommendations for reading. This book covers five management systems integrated into one novel approach that can be followed by organizations wishing to achieve quality and business excellence. Covering lean-six sigma – an essential element of management systems – it is a valuable resource for practitioners and academics alike.
Author: Fausto Pedro García Márquez
Publisher: BoD – Books on Demand
ISBN: 1789239079
Category : Technology & Engineering
Languages : en
Pages : 176
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Book Description
Lean Manufacturing, also called lean production, was originally created in Toyota after the Second World War, in the reconstruction period. It is based on the idea of eliminating any waste in the industry, i.e. any activity or task that does not add value and requires resources. It is considered in every level of the industry, e.g. design, manufacturing, distribution, and customer service. The main wastes are: over-production against plan; waiting time of operators and machines; unnecessary transportation; waste in the process itself; excess stock of material and components; non value-adding motion; defects in quality. The diversity of these issues will be covered from algorithms, mathematical models, and software engineering by design methodologies and technical or practical solutions. This book intends to provide the reader with a comprehensive overview of the current state, cases studies, hardware and software solutions, analytics, and data science in dependability engineering.
Author: Sarwar Beg
Publisher: Academic Press
ISBN: 0128163720
Category : Medical
Languages : en
Pages : 450
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Book Description
Pharmaceutical Quality by Design: Principles and Applications discusses the Quality by Design (QbD) concept implemented by regulatory agencies to ensure the development of a consistent and high-quality pharmaceutical product that safely provides the maximum therapeutic benefit to patients. The book walks readers through the QbD framework by covering the fundamental principles of QbD, the current regulatory requirements, and the applications of QbD at various stages of pharmaceutical product development, including drug substance and excipient development, analytical development, formulation development, dissolution testing, manufacturing, stability studies, bioequivalence testing, risk and assessment, and clinical trials. Contributions from global leaders in QbD provide specific insight in its application in a diversity of pharmaceutical products, including nanopharmaceuticals, biopharmaceuticals, and vaccines. The inclusion of illustrations, practical examples, and case studies makes this book a useful reference guide to pharmaceutical scientists and researchers who are engaged in the formulation of various delivery systems and the analysis of pharmaceutical product development and drug manufacturing process. - Discusses vital QbD precepts and fundamental aspects of QbD implementation in the pharma, biopharma and biotechnology industries - Provides helpful illustrations, practical examples and research case studies to explain QbD concepts to readers - Includes contributions from global leaders and experts from academia, industry and regulatory agencies
Author: Mr Arthur G Cook
Publisher: Ashgate Publishing, Ltd.
ISBN: 1472460111
Category : Business & Economics
Languages : en
Pages : 235
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Book Description
The second edition of Forecasting for the Pharmaceutical Industry continues to be a definitive guide for forecasters as well as the multitude of decision makers and executives who rely on forecasts in their decision making. The author explores the pharmaceutical forecasting process; the varied tools and methods for new product and in-market forecasting; how they can be used to communicate market dynamics to the various stakeholders; and the strengths and weaknesses of different forecast approaches. The second edition has been updated throughout and includes a brand new chapter focusing on specialized topics such as forecasting for orphan drugs and biosimilars.
Author: Erdem Gerard Tetteh
Publisher: IGI Global
ISBN: 1466673214
Category : Business & Economics
Languages : en
Pages : 365
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Book Description
"This book presents emerging research-based trends in the area of global quality lean six sigma networks and analysis through an interdisciplinary approach focusing on research, cases, and emerging technologies"--Provided by publisher.
Author: Clyde M. Creveling
Publisher: Pearson Education
ISBN: 0132712873
Category : Business & Economics
Languages : en
Pages : 322
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Book Description
Nearly half of the top one hundred Fortune 500 companies use Six Sigma methodology in some part of their business. These companies have been among the top one hundred for five or more years and consistently report higher revenue and significantly higher profits than competitors. This underscores the impact on the cost side. Now the focus moves to revenue growth. Six Sigma consultant Clyde M. Creveling’s Design for Six Sigma in Technology and Product Development is the standard guide for product commercialization and manufacturing support engineers who want to apply Six Sigma methodology to technology development and product commercialization. Now, in Six Sigma for Marketing Processes, Creveling joins with Lynne Hambleton and Burke McCarthy to show the ways marketing professionals can adapt and apply those same Six Sigma concepts to create a lean marketing workflow built for growth. This book provides an overview of the way marketing professionals can utilize the value offered by Six Sigma tools, methods, and best practices, within their existing phase-gate processes, as well as the traditional Six Sigma problem-solving approach: define, measure, analyze, improve, control (DMAIC). It provides unique methods for employing Six Sigma to enhance the three marketing processes for enabling a business to attain growth: strategic, tactical, and operational. It goes further to demonstrate the way Six Sigma for marketing and Six Sigma for design can be combined into a unified Six Sigma for growth. In this book, you’ll learn how to apply Six Sigma methodology to Develop a lean, efficient marketing workflow designed for growth Enhance the three marketing arenas for growth: strategic, tactical, and operational Identify leading indicators of growth and become proactive about performance improvement Strengthen links between customers, products, and profitability Redesign marketing work to streamline workflow and reduce variability Assess and mitigate cycle-time risk in any marketing initiative or project Leverage DMAIC to solve specific problems and improve existing processes Use lean techniques to streamline repeatable processes, such as collateral development and trade-show participation Preface xv Acknowledgments xxiii About the Authors xxv Chapter 1: Introduction to Six Sigma for Marketing Processes 1 Chapter 2: Measuring Marketing Performance and Risk Accrual Using Scorecards 25 Chapter 3: Six Sigma-Enabled Project Management in Marketing Processes 45 Chapter 4: Six Sigma in the Strategic Marketing Process 63 Chapter 5: Six Sigma in the Tactical Marketing Process 117 Chapter 6: Six Sigma in the Operational Marketing Process 173 Chapter 7: Quick Review of Traditional DMAIC 209 Chapter 8: Future Trends in Six Sigma and Marketing Processes 229 Glossary 235 Index 261
Author: Michael L. George
Publisher: McGraw Hill Professional
ISBN: 0071490353
Category : Business & Economics
Languages : en
Pages : 98
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Book Description
A quick introduction on how to use Lean Six Sigma toimprove your workplace, meet your goals, andbetter serve your customers. Lean Six Sigma combines the two most important improvement trends of our time: making work better (using Six Sigma) and making work faster (using Lean principles). In this plain-English guide, you’ll discover how this remarkable quality improvement method can give you the tools to identify and eliminate waste and quality problems in your own work area. Packed with diagrams, cartoons, and real-life examples, What is Lean Six Sigma? reveals the “four keys” of Lean Six Sigma and how they apply to your own job: Delight your customers with speed and quality Improve your processes Work together for maximum gain Base decisions on data and facts You’ll see the big picture of what your company hopes to gain with Lean Six Sigma, how it may affect your work area, and what it can mean to you personally.
Author: Markus Hammer
Publisher: Springer
ISBN: 365822939X
Category : Business & Economics
Languages : en
Pages : 273
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Book Description
Markus Hammer investigates a time-based and analytics-supported operations management approach. He explores five perspectives: 1) the needs of industry, in particular manufacturing in process industries, 2) the impact of digitization, with focus on Big Data and analytics, 3) the management of operations through time-based performance metrics, 4) how operations improvement methods and advanced process control help achieve resource-productive operations and 5) learning from practice based on two empirical case studies. The author conceives, explains, and tests an implementation methodology. The final case study proves that the developed implementation methodology works in practice.
