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Six Sigma In The Pharmaceutical Industry
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Book Synopsis Six Sigma in the Pharmaceutical Industry by : Brian K. Nunnally
Download or read book Six Sigma in the Pharmaceutical Industry written by Brian K. Nunnally and published by CRC Press. This book was released on 2007-06-13 with total page 222 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Applying Lean Six Sigma in the Pharmaceutical Industry by : Bikash Chatterjee
Download or read book Applying Lean Six Sigma in the Pharmaceutical Industry written by Bikash Chatterjee and published by CRC Press. This book was released on 2016-04-08 with total page 171 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Pharmaceutical Operations Management by : Pankaj Mohan
Download or read book Pharmaceutical Operations Management written by Pankaj Mohan and published by McGraw-Hill Professional. This book was released on 2006-03-16 with total page 264 pages. Available in PDF, EPUB and Kindle. Book excerpt: Publisher's Note: Products purchased from Third Party sellers are not guaranteed by the publisher for quality, authenticity, or access to any online entitlements included with the product. This book brings together a winning team of international operations experts to set the framework for building a world-class manufacturing organization. Pharmaceutical Operations Management focuses on key concepts such as: Policy Execution, Risk Management, Supply chain modeling, Advance process control and Six Sigma for the pharmaceutical industry: critical techniques which will offset cost, increase efficiency and turn any manufacture into financial winner.
Book Synopsis Design for Six Sigma in Technology and Product Development by : Clyde M. Creveling
Download or read book Design for Six Sigma in Technology and Product Development written by Clyde M. Creveling and published by Prentice Hall Professional. This book was released on 2002-10-25 with total page 1011 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book addresses many new topical areas for the development of 6 Sigma performance. The text is structured to demonstrate how 6 Sigma methods can be used as a very powerful tool within System Engineering and integration evaluations to help enable the process of Critical Parameter Management. The case studies and examples used throughout the book come from recent successful applications of the material developed in the text.
Book Synopsis Statistical Methods for Six Sigma by : Anand M. Joglekar
Download or read book Statistical Methods for Six Sigma written by Anand M. Joglekar and published by John Wiley & Sons. This book was released on 2003-09-19 with total page 339 pages. Available in PDF, EPUB and Kindle. Book excerpt: A guide to achieving business successes through statistical methods Statistical methods are a key ingredient in providing data-based guidance to research and development as well as to manufacturing. Understanding the concepts and specific steps involved in each statistical method is critical for achieving consistent and on-target performance. Written by a recognized educator in the field, Statistical Methods for Six Sigma: In R&D and Manufacturing is specifically geared to engineers, scientists, technical managers, and other technical professionals in industry. Emphasizing practical learning, applications, and performance improvement, Dr. Joglekar?s text shows today?s industry professionals how to: Summarize and interpret data to make decisions Determine the amount of data to collect Compare product and process designs Build equations relating inputs and outputs Establish specifications and validate processes Reduce risk and cost-of-process control Quantify and reduce economic loss due to variability Estimate process capability and plan process improvements Identify key causes and their contributions to variability Analyze and improve measurement systems This long-awaited guide for students and professionals in research, development, quality, and manufacturing does not presume any prior knowledge of statistics. It covers a large number of useful statistical methods compactly, in a language and depth necessary to make successful applications. Statistical methods in this book include: variance components analysis, variance transmission analysis, risk-based control charts, capability and performance indices, quality planning, regression analysis, comparative experiments, descriptive statistics, sample size determination, confidence intervals, tolerance intervals, and measurement systems analysis. The book also contains a wealth of case studies and examples, and features a unique test to evaluate the reader?s understanding of the subject.
Book Synopsis An Integrated Company-Wide Management System by : Souraj Salah
Download or read book An Integrated Company-Wide Management System written by Souraj Salah and published by Springer. This book was released on 2018-08-30 with total page 247 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis What Is Six Sigma? by : Peter S. Pande
Download or read book What Is Six Sigma? written by Peter S. Pande and published by McGraw Hill Professional. This book was released on 2001-11-16 with total page 97 pages. Available in PDF, EPUB and Kindle. Book excerpt: A brief introduction to Six Sigma for employees Six Sigma is today's most talked-about system for improving the quality of organizational processes. Written by bestselling author Peter Pande,What Is Six Sigma? is a concise summary of the core themes and processes of Six Sigma. Unlike almost all other books on Six Sigma, it is written for the employees of organizations rolling out Six Sigmanot just managers. This helpful overview describes what Six Sigma is, why companies are implementing it, and how employees can make it a success in their own organizations. Based on the bestselling The Six Sigma Way, this accessable introduction to Six Sigma answers typical employee questions, concerns, and even skepticism about this revolutionary program. Includes: The six themes of Six Sigma A five-step roadmap to Six Sigma implementation The 10 basic tools of Six Sigma, with an entire page devoted to each
Book Synopsis Leading Six Sigma by : Ronald D. Snee
Download or read book Leading Six Sigma written by Ronald D. Snee and published by FT Press. This book was released on 2003 with total page 316 pages. Available in PDF, EPUB and Kindle. Book excerpt: In Leading Six Sigma, two of the world's most experienced Six Sigma leaders offer a detailed, step-by-step strategy for leading Six Sigma initiatives in your company. Top Six Sigma consultant Dr. Ronald D. Snee and GE quality leader Dr. Roger W. Hoerl show how to deploy a Six Sigma plan that reflects your organization's unique needs and culture, while also leveraging key lessons learned by the world's most successful implementers. Snee and Hoerl share leadership techniques proven in companies both large and small, and in business functions ranging from R & D and manufacturing to finance. They also present a start-to-finish sample deployment plan encompassing strategy, goals, metrics, training, roles and responsibilities, reporting, rewards, and management review. Whether you're a CEO, line-of-business leader, or a project leader, Leading Six Sigma gives you the one thing other books on Six Sigma lack: a clear view from the top. * The right projects, the right people Identifying your company's most promising Six Sigma opportunities and leaders * How to hit the ground running Providing leadership, talent, and infrastructure for a successful launch * From launch to long-term success Implementing systems, processes, and budgets for ongoing Six Sigma projects * Getting the bottom-line results that matter most Measuring and maximizing the financial value of your Six Sigma initiative * Four detailed case studies: What works and what doesn't Avoiding the subtle mistakes that can make Six Sigma fall short. Proven techniques for leading successful quality initiatives. The Six Sigma guide designed specifically for business leaders Co-authored by Dr. Roger W. Hoerl, a leader in implementing Six Sigma at GE Draws on Six Sigma experiences at over 30 leading companies Covers the entire Six Sigma lifecycle, from planning onward Presents new solutions for overcoming the cultural resistance to Six Sigma initiatives Leading Six Sigma offers an insider's view of what it really takes to lead a successful Six Sigma initiative, drawing on the authors' experience at the top levels of the world's largest and most challenging organizations.Dr. Ronald D. Snee shares experiences drawn from executive-level consulting at over 30 major companies. Dr. Roger W. Hoerl teaches powerful lessons from his experience in pioneering Six Sigma throughout GE during the Jack Welch era. Together they offer unprecedented executive guidance on the issues most crucial to senior managers, covering every stage from planning through ongoingmanagement.Snee and Hoerl offer practical solutions for the cultural challenges and human resistance that face any executive seeking to initiate Six Sigma or improve an existing program. They even explain how and when to "wind down" initiatives, transitioning Six Sigma to a "fact of life" that doesn't require the support of a massive centralized infrastructure. " This is a truly insightful and well-researched book on Six Sigma by two of the leading experts in the field. Theirroadmap for successful deployment is supported by the experiences of major corporations, including GE and Honeywell. Itis extremely well presented in a step-by-step manner and backed up by real business-case examples. Bravo to the authors inbringing us a book that should be at the ready reach of leadership of organizations and the practitionersof Six Sigma. It reminded me so much of 'In Search of Excellence' as far as its potential impact on the way businessescan be successful. "&
Book Synopsis Six Sigma for Marketing Processes by : Clyde M. Creveling
Download or read book Six Sigma for Marketing Processes written by Clyde M. Creveling and published by Pearson Education. This book was released on 2006-02-17 with total page 322 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Book Synopsis Lean Manufacturing and Six Sigma by : Fausto Pedro García Márquez
Download or read book Lean Manufacturing and Six Sigma written by Fausto Pedro García Márquez and published by BoD – Books on Demand. This book was released on 2020-02-14 with total page 176 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Pharmaceutical Quality by Design by : Sarwar Beg
Download or read book Pharmaceutical Quality by Design written by Sarwar Beg and published by Academic Press. This book was released on 2019-03-27 with total page 450 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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
Book Synopsis World Class Applications of Six Sigma by : Jiju Antony
Download or read book World Class Applications of Six Sigma written by Jiju Antony and published by Routledge. This book was released on 2006-08-11 with total page 261 pages. Available in PDF, EPUB and Kindle. Book excerpt: World Class Applications shows what real organisations have done to implement Six Sigma, the methodology used, and the results delivered. The book provides details of how these organisations overcame issues with the statistical tools of Six Sigma and provides valuable lessons by explaining what went wrong when implementation failed. Cases cover topics including: Six Sigma in HR; Implementing Six Sigma in the Dow Chemical company; Six Sigma in IT; and Six Sigma to improve reporting quality.
Book Synopsis Global Supply Chains in the Pharmaceutical Industry by : Nozari, Hamed
Download or read book Global Supply Chains in the Pharmaceutical Industry written by Nozari, Hamed and published by IGI Global. This book was released on 2018-11-09 with total page 399 pages. Available in PDF, EPUB and Kindle. Book excerpt: In a rapidly growing global economy, where there is a constant emergence of new business models and dynamic changes to the business ecosystem, there is a need for the integration of traditional, new, and hybrid concepts in the complex structure of supply chain management. Within the fast-paced pharmaceutical industry, product strategy, life cycles, and distribution must maintain the highest level of agility. Therefore, organizations need strong supply chain capabilities to profitably compete in the marketplace. Global Supply Chains in the Pharmaceutical Industry provides innovative insights into the efforts needed to build and maintain a strong supply chain network in order to achieve efficient fulfillment of demand, drive outstanding customer value, enhance organizational responsiveness, and build network resiliency. This publication is designed for supply chain managers, policymakers, researchers, academicians, and students, and covers topics centered on economic cycles, sustainable development, and new forces in the global economy.
Book Synopsis What is Lean Six Sigma by : Michael L. George
Download or read book What is Lean Six Sigma written by Michael L. George and published by McGraw Hill Professional. This book was released on 2005-06-05 with total page 98 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Book Synopsis Kaizen for Pharmaceutical, Medical Device and Biotech Industries by : Shruti Bhat
Download or read book Kaizen for Pharmaceutical, Medical Device and Biotech Industries written by Shruti Bhat and published by ISBN Canada. This book was released on 2017-04-05 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: Kaizen procedures evolved in the automobile industry. Therefore, most of Kaizen literature, publications, books, cite Kaizen implementation in factories such as Toyota, Ford, Mazda and the like. But work practices within pharmaceutical, medical device and biotech industry are different from the auto sector. Regulations, customer demands, competitor landscape, product criteria, facility and environmental needs as well as employee skills within pharmaceutical (medical devices and biotech) companies are extremely stringent and totally different from the automobile industry. Therefore, 'as is' Kaizen practices from auto sector won't work for pharmaceutical, medical device, and biotech organizations. Kaizen needs to be customized for these life science industries, to achieve its full benefits. So far, there has been no book on Kaizen that is customized for such industries. For over a decade, the author, Dr. Shruti Bhat has successfully completed more than 250 Kaizen, Lean Six Sigma and other continuous improvement projects worldwide within pharmaceuticals NHP, medical devices, biotech and healthcare sectors, and felt it will be beneficial to share those techniques and experiences. In addition to explaining all the general Kaizen process features, implementation, and application, this book also provides a structured approach to designing Kaizen strategies, practices and implementation for pharmaceutical, medical device and biotech companies. This book will be most applicable to small to medium-size companies. It will demystify Kaizen and help business leaders in pharmaceutical, medical device, biotech and all life sciences organizations, irrespective of their size or workplace culture. It will also provide practical and useful examples and case studies of Kaizen principles that can be executed at various levels across the organization as well as for yourself as an individual to further your personal career. And last but not the least, it will help to improve revenues and create a lasting profitable change by using Kaizen principles and techniques.
Book Synopsis Good Manufacturing Practices for Pharmaceuticals by : Joseph D. Nally
Download or read book Good Manufacturing Practices for Pharmaceuticals written by Joseph D. Nally and published by CRC Press. This book was released on 2016-04-19 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control practices worldwide. An essential companion for every pharmaceutical professional, this guide is updated and expanded by a team of industry experts, each member with extensive experience in industry or academic settings.
Book Synopsis Six Sigma for Technical Processes by : Clyde M. Creveling
Download or read book Six Sigma for Technical Processes written by Clyde M. Creveling and published by Prentice Hall. This book was released on 2019-11-21 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Use Six Sigma to achieve and sustain excellence in product development and commercialization! To sustain growth and profitability, companies must tightly align product development and commercialization to fast-changing customer requirements. In this book, Clyde Creveling identifies the four process areas most crucial to doing so-and shows executives and managers how to optimize each of them. Creveling introduces a Six Sigma-enabled workflow that encompasses strategic product/technology portfolio definition and development, research and technology development (R&TD), tactical design engineering processes for commercialization, and operational production and service support. He presents tools, methods, and best practices for selecting the right projects, prioritizing them, and executing them rapidly, consistently, and successfully. Integrate all key technical processes so they work together in harmony Create Phase/Gate control plans for delivering products with minimal risk Establish scorecards for risk management in technical processes Use Six Sigma tools, such as Monte Carlo and FMEA, to improve project management Bring discipline to your product and technology portfolio renewal processes Systematically optimize your commercialization processes Define stripped-down "Fast Track" processes for commercializing high-risk, high-reward opportunities Provide effective operational support after you launch your product Preview the future of "lean" and Six Sigma in technical processes Use lean techniques to streamline repeatable processes such as R&D, product design, and post-launch production engineering support Learn how to manage the risk of doing a fast track commercialization project when you really must cut corners to get a product out into the market before your opportunity evaporates Foreword by John Boselli xiii Preface xv About the Author xxi Chapter 1: Introduction to Six Sigma for Technical Processes 1 Chapter 2: Scorecards for Risk Management in Technical Processes 21 Chapter 3: Project Management in Technical Processes 35 Chapter 4: Strategic Product and Technology Portfolio Renewal Process 51 Chapter 5: Strategic Research and Technology Development Process 95 Chapter 6: Tactical Product Commercialization Process 163 Chapter 7: Fast Track Commercialization 275 Chapter 8: Operational Post-Launch Engineering Support Processes 293 Chapter 9: Future Trends in Six Sigma and Technical Processes 317 Glossary 323 Index 351
