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Kaizen for Pharmaceutical, Medical Device and Biotech Industries

Kaizen for Pharmaceutical, Medical Device and Biotech Industries PDF Author: Shruti Bhat
Publisher:
ISBN: 9781520947846
Category :
Languages : en
Pages : 309

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.

Kaizen for Pharmaceutical, Medical Device and Biotech Industries

Kaizen for Pharmaceutical, Medical Device and Biotech Industries PDF Author: Shruti Bhat
Publisher:
ISBN: 9781520947846
Category :
Languages : en
Pages : 309

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.

Validation Standard Operating Procedures

Validation Standard Operating Procedures PDF Author: Syed Imtiaz Haider
Publisher: CRC Press
ISBN: 1420009419
Category : Medical
Languages : en
Pages : 1144

Book Description
Spanning every critical element of validation for any pharmaceutical, diagnostic, medical device or equipment, and biotech product, this Second Edition guides readers through each step in the correct execution of validating processes required for non-aseptic and aseptic pharmaceutical production. With 14 exclusive environmental performance evaluati

Applying Lean Six Sigma in the Pharmaceutical Industry

Applying Lean Six Sigma in the Pharmaceutical Industry PDF Author: Bikash Chatterjee
Publisher: CRC Press
ISBN: 1317180097
Category : Business & Economics
Languages : en
Pages : 242

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.

Quality Operations Procedures for Pharmaceutical, API, and Biotechnology

Quality Operations Procedures for Pharmaceutical, API, and Biotechnology PDF Author: Syed Imtiaz Haider
Publisher: CRC Press
ISBN: 1439886903
Category : Medical
Languages : en
Pages : 586

Book Description
To stay in compliance with regulations, pharmaceutical, medical, and biotech companies must create qualtiy SOPs that build in the regulatory requirements into actions and describe personal flow, internal flow, flow of information, and processing steps. Quality Operations Procedures for Pharmaceutical, API, and Biotechnology and the accompanying CD-ROM take into account all major international regulations, such as FDA, EU GMP, cGMP, GLP, PDA technical monographs, PDA technical reports, PMA concepts, journals of PDA, GCP, and industry standard ISO 9000, to be in compliance with documentation guidelines. No other resource deals exclusively with the key elements of quality control and quality assurance procedures for pharmaceutical operations and provides hands-on templates to be tailored to achieve global regulatory compliance. The book provides instant answers about what to include in critical quality assurance and quality control SOPs and how to enhance productivity. The CD-ROM contains nineteen quality control and thirty-three quality assurance SOPs designed so that users can input them into their computers and use their Microsoft Word programs to edit and print these documents. The book ensures minimization of the number of documents, helping to reduce the nightmare-like aura that surrounds an FDA audit. The SOPs exclusively refer to the documents specially required for compliance; however, specific formats are not included to ensure that the electronic templates can be easily used by pharmaceutical, bulk pharmaceutical, medical device, and biotechnology industries. The combination of text and CD-ROM presents a ready-to-use resource on the quality systems of aseptic pharmaceutical non-aseptic production and to provide general information and guidelines. They comprise a tool that can be used to develop a set of quality SOPs in order to support the road map established for the on-time successful start-up of the facility operation in compliance with the GMP requirements.

We Don't Build Cars; The Art of Sustained Competitive Improvement in the Drug and Medical Device Industries

We Don't Build Cars; The Art of Sustained Competitive Improvement in the Drug and Medical Device Industries PDF Author: William Botha
Publisher: Lulu.com
ISBN: 1257846272
Category : Business & Economics
Languages : en
Pages : 136

Book Description
An incisive and value-packed insight into the practical application of the Toyota Production System (or Lean) within the biopharmaceutical, pharmaceutical and medical devices industries. Written by a gifted trainer and leader in the niche, it is filled with tricks and traps on how best to navigate the treacherous minefield of regulations while generating significant and sustained benefit to the business and the patient. The Leanership model; integrating dynamic leadership behaviors with robust control systems and effective TPS tools, is described within the covers. The author, as a result of his time as a leader, manager, trainer and consultant is able to tell relevant personal stories to illuminate the key concepts and philosophies that will enable the reader to replicate his results. Illustrated with profound quotes from world leaders and salted with a quirky sense of humor, this treasure of a work is an easy, fast read.

Pharmaceutical and Biomedical Project Management in a Changing Global Environment

Pharmaceutical and Biomedical Project Management in a Changing Global Environment PDF Author: Scott D. Babler
Publisher: John Wiley & Sons
ISBN: 1118058216
Category : Medical
Languages : en
Pages : 277

Book Description
Pharmaceutical and Biomedical Portfolio Management in a Changing Global Environment explores some of the critical forces at work today in the complex endeavour of pharmaceutical and medical product development. Written by experienced professionals, and including real-world approaches and best practice examples, this new title addresses three key areas – small molecules, large molecules, and medical devices - and provides hard-to-find, consolidated information relevant to and needed by pharmaceutical, biotech, and medical device company managers.

A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry

A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry PDF Author: Nuala Calnan
Publisher: CRC Press
ISBN: 1315351366
Category : Medical
Languages : en
Pages : 357

Book Description
This book addresses the rapidly emerging field of Knowledge Management in the pharmaceutical, medical devices and medical diagnostics industries. In particular, it explores the role that Knowledge Management can play in ensuring the delivery of safe and effective products to patients. The book also provides good practice examples of how the effective use of an organisation’s knowledge assets can provide a path towards business excellence.

Quality by Design for Biopharmaceuticals

Quality by Design for Biopharmaceuticals PDF Author: Anurag S. Rathore
Publisher: John Wiley & Sons
ISBN: 1118210913
Category : Science
Languages : en
Pages : 279

Book Description
The concepts, applications, and practical issues of Quality by Design Quality by Design (QbD) is a new framework currently being implemented by the FDA, as well as EU and Japanese regulatory agencies, to ensure better understanding of the process so as to yield a consistent and high-quality pharmaceutical product. QbD breaks from past approaches in assuming that drug quality cannot be tested into products; rather, it must be built into every step of the product creation process. Quality by Design: Perspectives and Case Studies presents the first systematic approach to QbD in the biotech industry. A comprehensive resource, it combines an in-depth explanation of basic concepts with real-life case studies that illustrate the practical aspects of QbD implementation. In this single source, leading authorities from the biotechnology industry and the FDA discuss such topics as: The understanding and development of the product's critical quality attributes (CQA) Development of the design space for a manufacturing process How to employ QbD to design a formulation process Raw material analysis and control strategy for QbD Process Analytical Technology (PAT) and how it relates to QbD Relevant PAT tools and applications for the pharmaceutical industry The uses of risk assessment and management in QbD Filing QbD information in regulatory documents The application of multivariate data analysis (MVDA) to QbD Filled with vivid case studies that illustrate QbD at work in companies today, Quality by Design is a core reference for scientists in the biopharmaceutical industry, regulatory agencies, and students.

Kaizen for Pharmaceutical, Medical Device and Biotech Industries

Kaizen for Pharmaceutical, Medical Device and Biotech Industries PDF Author: Shruti Bhat
Publisher: ISBN Canada
ISBN: 9781988663043
Category :
Languages : en
Pages :

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.

Medical Device Quality Management Systems

Medical Device Quality Management Systems PDF Author: Susanne Manz
Publisher: Academic Press
ISBN: 0128142227
Category : Science
Languages : en
Pages : 298

Book Description
Medical Devices Quality Management Systems: Strategy and Techniques for Improving Efficiency and Effectiveness is written for the needs of quality, compliance, and regulatory professionals in medical device companies. It includes secrets for developing an effective, yet efficient, Quality Management System (QMS) and explains how to create a vision, strategy, and tactical plans. Author Manz shares lessons on leadership, key roles and responsibilities within a medical device company, while also exploring the concepts of process ownership, individual accountability, and how to cultivate a culture of quality and compliance. This book is useful for all executive, functional leaders, and organizations in the highly regulated medical device industry. Provides practical, real-world guidance on developing an effective and efficient Quality Management System Presents a roadmap for QMS development Covers techniques to assess current state Includes discussions on tools, such as CAPA and Six Sigma that help define vision, strategy and quality plans