Author: Shruti Bhat
Publisher:
ISBN: 9781520947846
Category :
Languages : en
Pages : 309
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Book Description
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.Some salient features of this book:* This book presents useful ideas that one can implement immediately, often at no additional cost. * It shows how to transform a business from 'good- to- great'. True benefits of Kaizen implementation are realized because it adds value to your products, increases market share, and drives both top and bottom lines of your business. * It shows pharmaceutical & biotech scientists, design engineers, operators and everyone involved in product development, how to utilize Kaizen- to create innovations, conduct successful scale-up and technology transfer to manufacturing sites.* It shows the company's senior management, how to use Kaizen to increase ROI (return on investment) while complying with cGMP (current Good Manufacturing Practices) and other regulations, address any rising competition and counteract fluctuating market economy. * Kaizen has mainly been used in Japan and many other SE Asian companies and in Europe. Up until now, it has not gained enough significance in North America, because of which it has not been utilized to its full potential. The root cause is the difference in work culture and corporate governance styles of companies in eastern and western countries; this book totally eliminates this gap and presents Kaizen methodology for direct implementation within any pharmaceutical, medical device or biotech company; in east or west.* This book can also be an excellent resource for Kaizen beginners with a lot of real life industry examples, case studies and several 'do-it-yourself' exercises, which is of tremendous value, in absence of a Kaizen coach.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.
Author: Shruti Bhat
Publisher: ISBN Canada
ISBN: 9781988663043
Category :
Languages : en
Pages :
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Book Description
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.
Author: Shruti U. Bhat
Publisher: ISBN Canada
ISBN: 9781988663111
Category :
Languages : en
Pages :
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Book Description
Continuous Improvement- 30 Proven tools to drive Profitability, Quality and Operational Effectiveness in Manufacturing & Service Industry, is the fourth book of "Business Process Management Systems and Continuous Improvement Executive Guide Series." If you want new and effective ideas to improve your organization's efficiency, then this self-help business management book is for you. For Continuous Improvement efforts to be effective, meaningful, realistic and sustainable, it is important to use appropriate tools. Tools that will facilitate correct identification of business problems, provide required change metrics along with assisting strategic decision-making and cost-effective implementation. This book provides deep insights into 30 vital tools necessary to conduct successful Continuous Improvement campaigns. Who should read this book? This book is for Agile entrepreneurs, Startups, Leaders, QA (Quality Assurance) managers, Management consulting professionals, Production supervisors, Project leaders, Manufacturing heads, CEOs, Directors and Managers involved in decision-making, directing their organization's sustainability, profitability, and expansion. This book is also for professionals who are interested in making a career change and wish to embrace business process management (bpm) role. This book helps executives; professionals improve organizational performance in their role as a Management Consultant, Business Analyst, Continuous Improvement, or Process Management Expert. This book is also for graduate students in the process of stepping into the industrial world- be it manufacturing or a service industry. This book is not body of knowledge (BoK) for a certification exam. This book is not only meant for Business Management professionals and Process Architects & Analysts, but also for all business readers who wish to apply business improvement methodology tools in most effective, beneficial and practical ways.
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.
Author: Feroz Jameel
Publisher: Springer
ISBN: 1493923161
Category : Medical
Languages : en
Pages : 710
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Book Description
This volume explores the application of Quality by Design (QbD) to biopharmaceutical drug product development. Twenty-eight comprehensive chapters cover dosage forms, liquid and lyophilized drug products. The introductory chapters of this book define key elements of QbD and examine how these elements are integrated into drug product development. These chapters also discuss lessons learned from the FDA Office of Biotechnology Products pilot program. Following chapters demonstrate how QbD is used for formulation development ranging from screening of formulations to developability assessment to development of lyophilized and liquid formats. The next few chapters study the use of small-scale and surrogate models as well as QbD application to drug product processes such as drug substance freezing and thawing, mixing, sterile filtration, filling, lyophilization, inspection and shipping and handling. Later chapters describe more specialized applications of QbD in the drug product realm. This includes the use of QbD in primary containers, devices and combination product development. The volume also explores QbD applied to vaccine development, automation, mathematical modeling and monitoring, and controlling processes and defining control strategies. It concludes with a discussion on the application of QbD to drug product technology transfer as well as overall regulatory considerations and lifecycle management. Quality by Design for Biopharmaceutical Drug Product Development is an authoritative resource for scientists and researchers interested in expanding their knowledge on QbD principles and uses in creating better drugs.
Author:
Publisher:
ISBN:
Category : American literature
Languages : en
Pages : 3310
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Book Description
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: Shruti U. Bhat
Publisher: ISBN Canada
ISBN: 9781988663104
Category :
Languages : en
Pages :
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Book Description
Finally, a resource which is a Go-To reference handbook for selecting appropriate Business Process Improvement methodology! Up to speed with workflow- How to choose business process improvement methodology for your organization and measure the positive change, is the third book of "Business Process Management Systems and Continuous Improvement Executive Guide series." Businesses constantly strive to provide better customer experience while also increasing productivity and profitability. While doing this, they run into several challenges such as inconsistent cash flow, poor dales, customer dissatisfaction along with manufacturing & logistic issues related to reworks and backorders. The key questions that face a Business Process Improvement team are "How to select a business process improvement strategy from among 23 time-tested methods? How to determine which methodology is most suitable for addressing your specific issues and workplace concerns? How to chose a strategy that can bring faster turnaround and a greater return on investment? This go-to reference book provides answers to these and other such crucial questions...
Author: Kennedy Information
Publisher:
ISBN: 9781932079333
Category : Business & Economics
Languages : en
Pages : 1122
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Book Description
Whether an executive is seeking a position at a brewery or a software firm, this volume has the contacts that can make or break a job search.
Author: Paul T. Anastas
Publisher:
ISBN:
Category : Science
Languages : en
Pages : 216
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Book Description
Describes the current status and potential of synthetic chemistry designed to use and to generate fewer hazardous substances. Examines new techniques for carrying out transformations in environmentally benign solvent systems. Presents research results on the replacement of hazardous feedstocks with biologically derived, innocuous feedstocks; of hazardous reagents with visible light; and of phosgene, benzene, and halogens in a variety of industrially important reactions. Provides examples of how alternative synthetic design for pollution prevention has been made commercially viable. Describes how to conduct a source-reduction assessment and analyzes computer-assisted synthetic design.
