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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: Ntin Kapoor
Publisher: Lulu.com
ISBN: 1304064468
Category : Business & Economics
Languages : en
Pages : 37
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Book Description
Due to the origin of Lean, it is widely used in manufacturing focussed companies like automotive industry but in current scenario the concept of Lean Manufacturing has been adopted by different businesses as well. In view of this, the objective of the report is to study the different approaches of Lean Manufacturing and the challenges which Pharma companies are facing in implementation of Lean Manufacturing and also the progress report of some companies to know whether any drug manufacture has truly made some progress or not.
Author: Terence Barnhart
Publisher: CRC Press
ISBN: 1439800804
Category : Business & Economics
Languages : en
Pages : 267
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Book Description
The ability to find and remove barriers between people and their systems in R&D can almost guarantee a doubling in performance, and often delivers multiples of that. R&D teams that have smooth handoffs deliver 100 percent of the required knowledge at those handoffs. As a result, such teams do not lose critical information, have unexpected k
Author: Nigel J Smart
Publisher: Elsevier
ISBN: 1908818409
Category : Science
Languages : en
Pages : 384
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Book Description
With decreasing profit margins, increasing cost pressures, growing regulatory compliance concerns, mounting pressure from generic drugs and increasing anxiety about the future of healthcare reimbursement, pharmaceutical manufacturers are now forced to re-examine and re-assess the way they have been doing things. In order to sustain profitability, these companies are looking to reduce waste (of all kinds), improve efficiency and increase productivity. Many of them are taking a closer look at lean manufacturing as a way to achieve these goals. Lean biomanufacturing re-visits lean principles and then applies them sympathetically - in a highly practical approach - to the specific needs of pharmaceutical processes, which present significantly different challenges to more mainstream manufacturing processes. A major goal of the book is to highlight those problems and issues that appear more specific or unique to biopharmaceutical manufacturing situations and to provide some insights into what challenges are the important ones to solve and what techniques, tools and mechanisms to employ to be successful.Following an introduction to lean biomanufacturing, the book goes on to discuss lean technologies and methods applied in biomanufacturing. Later chapters cover the creation and implementation of the Transition Plan, issues facing the biopharmaceutical industry, creating a lean approach towards biopharmaceutical processes and the contribution of simulation models in developing these processes. The final chapter covers examples of new technology innovations which help facilitate lean biomanufacturing. - A focus on the issues associated with the application of lean principles to biomanufacturing - Practical examples of factors which can affect biopharmaceutical processes - Coverage of key factors which require integration to run an efficient biopharmaceutical process
Author: Peter L. King
Publisher: Productivity Press
ISBN: 9780367023324
Category : Lean manufacturing
Languages : en
Pages : 340
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Book Description
Drawing on 40 years of application experience at one of the world's largest chemical and materials manufacturers, King provides the first comprehensive resource written explicitly for change agents within the process industries.
Author: Dennis P. Hobbs
Publisher: J. Ross Publishing
ISBN: 9781932159141
Category : Business & Economics
Languages : en
Pages : 270
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Book Description
The Lean Manufacturing Implementation Guide is a "how to" book that describes and documents the proven steps necessary to complete a successful lean transformation in a manufacturing facility. It reduces the manufacturer's fear of change by providing proven, objective and standard how to methods that are understandable and can be easily applied. The book is designed for manufacturing and engineering management personnel.
Author: Abdurrahman Coskun
Publisher: BoD – Books on Demand
ISBN: 9533073705
Category : Business & Economics
Languages : en
Pages : 198
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Book Description
In the new millennium the increasing expectation of customers and products complexity has forced companies to find new solutions and better alternatives to improve the quality of their products. Lean and Six Sigma methodology provides the best solutions to many problems and can be used as an accelerator in industry, business and even health care sectors. Due to its flexible nature, the Lean and Six Sigma methodology was rapidly adopted by many top and even small companies. This book provides the necessary guidance for selecting, performing and evaluating various procedures of Lean and Six Sigma. In the book you will find personal experiences in the field of Lean and Six Sigma projects in business, industry and health sectors.
Author: Mitchell M. Tseng
Publisher: Springer Science & Business Media
ISBN: 3642554601
Category : Business & Economics
Languages : en
Pages : 528
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Book Description
Companies are being forced to react to the growing individualization of demand. At the same time, cost management remains of paramount importance due to the competitive pressure in global markets. Thus, making enterprises more customer centric efficiently is a top management priority in most industries. Mass customization and personalization are key strategies to meet this challenge. Companies like Procter&Gamble, Lego, Nike, Adidas, Land's End, BMW, or Levi Strauss, among others, have started large-scale mass customization programs. This book provides insight into the different aspects of building a customer centric enterprise. Following an interdisciplinary approach, leading scientists and practitioners share their findings, concepts, and strategies from the perspective of design, production engineering, logistics, technology and innovation management, customer behavior, as well as marketing.
Author: Fabrizio Giordanetto
Publisher: John Wiley & Sons
ISBN: 3527341498
Category : Science
Languages : en
Pages : 810
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Book Description
This one-stop reference systematically covers key aspects in early drug development that are directly relevant to the discovery phase and are required for first-in-human studies. Its broad scope brings together critical knowledge from many disciplines, ranging from process technology to pharmacology to intellectual property issues. After introducing the overall early development workflow, the critical steps of early drug development are described in a sequential and enabling order: the availability of the drug substance and that of the drug product, the prediction of pharmacokinetics and -dynamics, as well as that of drug safety. The final section focuses on intellectual property aspects during early clinical development. The emphasis throughout is on recent case studies to exemplify salient points, resulting in an abundance of practice-oriented information that is usually not available from other sources. Aimed at medicinal chemists in industry as well as academia, this invaluable reference enables readers to understand and navigate the challenges in developing clinical candidate molecules that can be successfully used in phase one clinical trials.
Author: Hedley Rees
Publisher: John Wiley & Sons
ISBN: 0470922842
Category : Medical
Languages : en
Pages : 458
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Book Description
This book bridges the gap between practitioners of supply-chain management and pharmaceutical industry experts. It aims to help both these groups understand the different worlds they live in and how to jointly contribute to meaningful improvements in supply-chains within the globally important pharmaceutical sector. Scientific and technical staff must work closely with supply-chain practitioners and other relevant parties to help secure responsive, cost effective and risk mitigated supply chains to compete on a world stage. This should not wait until a drug has been registered, but should start as early as possible in the development process and before registration or clinical trials. The author suggests that CMC (chemistry manufacturing controls) drug development must reset the line of sight – from supply of drug to the clinic and gaining a registration, to the building of a patient value stream. Capable processes and suppliers, streamlined logistics, flexible plant and equipment, shorter cycle times, effective flow of information and reduced waste. All these factors can and should be addressed at the CMC development stage.
