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.

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.

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.

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.

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

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.

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

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.

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.

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. "&

Download or read book Validation of Pharmaceutical Processes written by James P. Agalloco and published by CRC Press. This book was released on 2007-09-25 with total page 762 pages. Available in PDF, EPUB and Kindle. Book excerpt: Completely revised and updated to reflect the significant advances in pharmaceutical production and regulatory expectations, this third edition of Validation of Pharmaceutical Processes examines and blueprints every step of the validation process needed to remain compliant and competitive. The many chapters added to the prior compilation examine va

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

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.

Download or read book Industrial Pharmacy written by Dr Muralidhar, Dr Narmada and published by Notion Press. This book was released on 2024-02-03 with total page 281 pages. Available in PDF, EPUB and Kindle. Book excerpt: Industrial Pharmacy: From Pilot Plant to Market" is a comprehensive guide that provides practical approaches to pharmaceutical product development. With 37 exhaustive chapters, it covers important topics such as pilot plant scale-up techniques, technology transfer protocols, regulatory requirements, quality management systems, and Indian regulatory requirements. The book helps readers understand the significance of personnel requirements, space requirements, raw materials, and relevant documentation for solids, liquid orals, and semi-solids. It also provides insights into WHO guidelines for technology transfer, clinical research protocols, quality management concepts, ISO quality systems standards, and Indian regulatory requirements. This book is an essential resource for pharmaceutical professionals and students who seek to advance healthcare through innovative pharmaceutical product development.

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.

Download or read book Multivariate Analysis in the Pharmaceutical Industry written by Ana Patricia Ferreira and published by Academic Press. This book was released on 2018-04-24 with total page 465 pages. Available in PDF, EPUB and Kindle. Book excerpt: Multivariate Analysis in the Pharmaceutical Industry provides industry practitioners with guidance on multivariate data methods and their applications over the lifecycle of a pharmaceutical product, from process development, to routine manufacturing, focusing on the challenges specific to each step. It includes an overview of regulatory guidance specific to the use of these methods, along with perspectives on the applications of these methods that allow for testing, monitoring and controlling products and processes. The book seeks to put multivariate analysis into a pharmaceutical context for the benefit of pharmaceutical practitioners, potential practitioners, managers and regulators. Users will find a resources that addresses an unmet need on how pharmaceutical industry professionals can extract value from data that is routinely collected on products and processes, especially as these techniques become more widely used, and ultimately, expected by regulators. - Targets pharmaceutical industry practitioners and regulatory staff by addressing industry specific challenges - Includes case studies from different pharmaceutical companies and across product lifecycle of to introduce readers to the breadth of applications - Contains information on the current regulatory framework which will shape how multivariate analysis (MVA) is used in years to come

Download or read book Impact of FDI on the Growth of Pharmaceutical Sector in India A Study with Special Reference to Post Liberalization Scenario written by Dr. SYED KHAJA SAFIUDDIN and published by Archers & Elevators Publishing House. This book was released on with total page 338 pages. Available in PDF, EPUB and Kindle. Book excerpt: