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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: William Botha
Publisher:
ISBN: 9780470411612
Category :
Languages : en
Pages : 336
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Book Description
Lean manufacturing focuses on speed, while traditional Six Sigma focuses on quality. Striking a perfect balance between these two business paradigms, Lean Six Sigma in the Pharmaceutical Industry introduces key lean six sigma principles to help readers improve the quality and efficiency of medical products and the predictability of supply chains. Rich with forms and charts, the book pharma companies and biotech industry professionals with an indispensable tool for implement a lean six sigma program internally rather than hiring an outside consulting firm.
Author: Thomas Friedli
Publisher: Springer Science & Business Media
ISBN: 3642351611
Category : Business & Economics
Languages : en
Pages : 536
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Book Description
Achieving operational excellence is a challenge for the pharmaceutical industry, with many companies setting successful examples time and again. This book presents such leading practices for managing operational excellence throughout the pharmaceutical industry. Based on the St.Gallen OPEX Model the authors describe the current status of OPEX and the future challenges that have to be dealt with. The ample theoretical background is complemented hand-in-hand by case studies contributed by authors from leading pharmaceutical companies.
Author: Estela Niazi
Publisher:
ISBN:
Category : Medical instruments and apparatus industry
Languages : en
Pages : 194
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Book Description
Author: James P. Agalloco
Publisher: CRC Press
ISBN: 1420019791
Category : Medical
Languages : en
Pages : 762
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Book Description
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
Author: Geoff Tennant
Publisher: Taylor & Francis
ISBN: 1351899813
Category : Business & Economics
Languages : en
Pages : 155
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Book Description
’Six Sigma’ is a quality concept initially used by Motorola and then developed beyond manufacturing by GE Capital. It has underpinned that organisation's phenomenal success. In essence it is a way of scientifically measuring your current success (or failure) rate in relation to customer expectations (regardless of industry sector) and then ensuring that improvements are made. Six Sigma is the application of a new model of working, statistical measurement and process control to TQM. The ’normal’ position of businesses today is three sigma (or a defect rate of about 5-10%); six sigma - a defect rate of less than four in every million - is the ultimate goal. This book explains the concept of Six Sigma and its statistical basis; explains the benefits which can be achieved by using it in any company and then outlines how to implement such a programme.
Author: Kieran O'Riordan
Publisher:
ISBN:
Category :
Languages : en
Pages :
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Book Description
Author: Dr Muralidhar, Dr Narmada
Publisher: Notion Press
ISBN:
Category : Medical
Languages : en
Pages : 281
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Book Description
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.
Author: Ana Patricia Ferreira
Publisher: Academic Press
ISBN: 012811066X
Category : Medical
Languages : en
Pages : 465
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Book Description
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
