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, environmental needs, 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 must be customized for these industries, to achieve its full benefits. So far, there has been no book on Kaizen that is customized to pharmaceutical, medical device, and biotech industries. Having successfully driven more than 250 Kaizen, Lean Six Sigma, and other continuous improvement projects within pharmaceuticals, NHP, medical devices, biotech sectors, worldwide for over a decade, I have created real success stories; I felt it will be beneficial to share those techniques and experiences. This book is a structured approach to designing Kaizen strategies, practices and implementation for pharmaceutical, medical device, and biotech companies. This book is to: Demystify Kaizen and help business leaders in pharmaceutical, medical device, biotech, and all life sciences organizations, irrespective of their size or workplace culture. Provide practical and useful examples and case studies 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. Improve revenues and create a lasting change using Kaizen principles and techniques. Some salient features of this book: It shows pharmaceutical & biotech scientists, design engineers, operators and everyone involved in product development, how to utilize Kaizen- to create innovations. 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 rising competition and counteract fluctuating market economy. 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 line and bottom line of your business. 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 in work culture and corporate governance styles of companies in eastern and western countries; this book totally eliminates this gap. This book presents Kaizen methodology for direct implementation within a pharmaceutical, medical device, biotech company in east or west. Moreover, this book helps you to customize Kaizen to your company; this book is not a 'vanilla generic'. In addition, this book is an excellent resource for Kaizen beginners with a of real life industry examples, case studies and provides several 'do-it-yourself' exercises, which is of tremendous value, in absence of a Kaizen coach.
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