Download or read book Leading Pharmaceutical Operational Excellence written by Thomas Friedli and published by Springer Science & Business Media. This book was released on 2013-11-26 with total page 536 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Operational Excellence in the Pharmaceutical Industry written by Daniel Bellm and published by . This book was released on 2015 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: Launching Operational Excellence (OPEX) constitutes a true challenge for every manufacturing organization. Changing the habits and behavior of people, making them to leave the beaten track and ultimately changing their mindset to continuous improvement is a real management task and demands leaders to be charismatic, encouraging and tenacious. This especially holds true for the highly regulated pharmaceutical industry and its heritage of reluctance to change. Nevertheless, most large pharmaceutical organizations based in advanced economies have launched an OPEX program in an effort to holistically improve their operations since the turn of the millennium. Moreover, after the first results and realized benefits have been publicized, the transformational concept found its way to small and medium-sized pharmaceutical manufactures and did not stop to enter domestic organizations of the so called emerging markets. These markets distinguish substantially from advanced economies and their unique setup make it nearly impossible, to transfer the concepts that work perfectly in western organizations to domestic emerging market manufacturers without any localized adaptions. This dissertation suggests an approach how domestic pharmaceutical manufacturers in emerging markets can design their individual OPEX program that fits to their specific internal and external requirements. First, two literature reviews examine the knowledge base on emerging markets and OPEX. These reviews provide deep insights into what constitutes an emerging market and list the major influences of these markets towards domestic manufacturing sites. Furthermore, the philosophy and elements of OPEX are analyzed and critically reflected within a pharmaceutical and emerging market context. Second, a benchmarking of OPEX practices of 267 pharmaceutical manufacturing sites allows the comparison of sites in advanced and emerging markets. Subsequent case studies and workshop.
Download or read book The Pathway to Operational Excellence in the Pharmaceutical Industry written by Thomas Friedli and published by . This book was released on 2010 with total page 365 pages. Available in PDF, EPUB and Kindle. Book excerpt: Neue Technologien, sich wandelnde Geschäftsstrategien, Kostendruck auf Hersteller und Zulieferer, migrierende globale Wertschöpfungsketten sowie neue regulatorische Anforderungen sind die Herausforderungen der Pharmaindustrie. Um in allen Bereichen Exzellenz zu erreichen gilt es, den Fokus auf die Menschen zu richten. Sie planen, bewirken, verbessern und erfinden neue Strategien, erfahren, Systeme und Strukturen. Die Fähigkeit zur Überwindung der inneren Trägheit eines Unternehmens macht den Unterschied. Die höchsten FundE-Ausgaben verzeichneten die Unternehmen, die sich nicht weiter mit einem eingeführten und evaluierten Verfahren beschäftigten. Das beeinträchtigte Innovationen im Produkt- und Substanzbereich. Veränderungen werden an Geschwindigkeit und Umfang zunehmen. Hier setzt die Operational Excellence ein. Dies impliziert, das Herstellungspotenzial zu entwickeln, als Grundlage einzigartiger Geschäftsstrategien. Dazu erforderlich sind Exzellenz in Führung und Management, Methoden und Tools sowie Technologie und Innovation. Zielgruppen:- Pharmazeutische Industrie- Zulieferindustrie- Fachhochschulen / Universitäten- Beratungsunternehmen- Behörden.
Download or read book Operational Excellence in the Pharmaceutical Industry written by Daniel Bellm and published by . This book was released on 2015 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Operational Excellence in the Pharmaceutical Industry written by Thomas Friedli and published by . This book was released on 2006 with total page 190 pages. Available in PDF, EPUB and Kindle. Book excerpt: In dem Buch werden die Ergebnisse einer Benchmark-Studie zum Thema "Operational Excellence in der Pharmaindustrie", die von der Universität St. Gallen und der Arbeitsgemeinschaft für Pharmazeutische Verfahrenstechnik e. V. (APV) durchgeführt wurde, zusammengefaßt und ausgewertet. Über 100 Pharma-Produktionsstätten in mehr als 20 europäischen Ländern wurden im Rahmen der Studie hinsichtlich des Ist-Zustandes ihrer Produktionsperformance unter besonderer Berücksichtigung der Anforderungen des "Lean Managements" untersucht. Die Autoren geben eine detaillierte Übersicht über die Studienergebnisse und präsentieren einen umfangreichen Maßnahmenkatalog, mit dessen Hilfe eine Steigerung der Operational Excellence von Pharma-Produktionsanlagen erreicht werden kann. Die Ergebnisse von sieben beispielhaften Fallstudien, die besonders umfangreich analysiert wurden, sowie ein Ausblick auf die wesentlichen sich bereits abzeichnenden technologischen Weiterentwicklungen im Bereich Pharma-Produktion vermitteln dem Leser praxisnahes und hilfreiches Wissen, um Verbesserungspotentiale im eigenen betrieblichem Umfeld analysieren und umsetzen zu können. Führende Pharma-Experten aus den Bereichen Management sowie Forschung & Entwicklung haben dazu beigetragen, das Thema Operational Excellence erstmals aus Sicht der Pharmaindustrie umfassend zu behandeln. Zielgruppen:- Pharmazeutische Industrie- Auftragshersteller- Zulieferindustrie- Anlagenbau- Planungsunternehmen- Consulting-Unternehmen- Universitäten und Fachhochschulen- Behörden (Überwachungsämter).
Download or read book Achieving Business and Operational Excellence in the Pharmaceutical Industry written by Shonna Marie Coffey and published by . This book was released on 2008 with total page 114 pages. Available in PDF, EPUB and Kindle. Book excerpt: (Cont.) First, substantial improvement opportunities exist within current pharmaceutical manufacturing. Second, pharmaceutical companies must build operational efficiencies into manufacturing process design. Lastly, operational excellence cannot simply be attained through the implementation of an improvement toolkit.
Download or read book Sustainable Implementation of Operational Excellence Initiatives written by Alexandra Ettlin and published by . This book was released on 2013 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: In order to fulfill the growing need for agility and flexibility and to handle increasing production complexity, pharmaceutical manufacturing's strategic importance has risen. However, many companies are just starting to discover the potential and benefits of Operational Excellence initiatives. This thesis has two main parts: a theoretical base, which analyzes the development of integrated production systems and explores their origins in post-war Japan, as well as discussion of OPEX initiative elements across the whole industry scale. The second section is comprised of an exhaustive operational excellence questionnaire focusing on OPEX initiatives within six globally active pharmaceutical companies. Every company surveyed was different; research and literature has not yet been able to provide an answer about the correct structure and the number of people within a company needed to sustainably implement an OPEX initiative. Making a fundamental effort to change company philosophy and empowering employees to realize their own and the company's full potential should be the long-term goal of a meaningful OPEX effort. This vision must then be translated into reality through structures within the organization: through middle managers, who serve as a crucial link between corporate and site level, project teams who are evaluated according to project targets and employees at all levels who are granted sufficient time and resources to fully support and sponsor the initiative in all of its stages. Finally, promising organizational success factors are visualized in an "OPEX implementation house" model.
Download or read book Applying Lean Six Sigma in the Pharmaceutical Industry written by Bikash Chatterjee and published by CRC Press. This book was released on 2016-04-08 with total page 171 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Quality as the Foundation for Excellence written by Christian Mänder and published by . This book was released on 2016 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: The changes in production environment in today's pharmaceutical industry are a challenge for almost every pharmaceutical company. With the increase in the global demand of drugs through demographic change and the medicine demand of emerging countries, the required quantity of pharmaceuticals will increase significantly in upcoming years. The industry struggles with the dual problem of drug shortages - which have quadrupled in recent years - and an increasing number of drug recalls. In general, regulatory pressure and current regulatory changes are forcing the pharmaceutical industry to develop a stable quality oriented production system. Thus, in the increasingly complex environment of the pharmaceutical industry, companies need to take a closer look at their quality organisation in order to stabilise their internal production system and increase their flexibility and overall performance. Due to this need, the research focuses on the investigation of the interdependencies of quality and excellence to leverage the advantages of both. Operational Excellence (OPEX), as an initiative and lived as a philosophy, leads to a better performance, more efficient use of resources and continuous improvement. Quality management approaches have a positive impact on quality, innovation and the overall performance. Even though well-known excellence models include quality as basic element, the examples from practice show that the pharmaceutical industry discusses these aspects self-sufficiently. The divide of quality and excellence is not a conceptual problem but an industry-made challenge. Based on an extensive literature review, a statistical evaluation, a benchmarking and a qualitative case study analysis, the thesis designs a descriptive model that builds the basis to structure an internal quality management system for pharmaceutical companies, using a systemic approach combining quality and excellence. In addition, the thesis introduce.
Download or read book A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry written by Nuala Calnan and published by CRC Press. This book was released on 2017-06-26 with total page 357 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Applying Lean Six Sigma in the Pharmaceutical Industry written by Bikash Chatterjee and published by CRC Press. This book was released on 2016-04-08 with total page 173 pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book State of Readiness written by Joseph F. Paris Jr. and published by Greenleaf Book Group. This book was released on 2017-05-16 with total page 400 pages. Available in PDF, EPUB and Kindle. Book excerpt: Accelerated Strategy Development and Execution The company of today has its supply chains and finances stretched further around the globe than ever before while simultaneously having increasing pressures to drive value across a complicated and fluid set of metrics and deliver innovations, products, and services more quickly and reliably. The competitive advantage belongs to the companies that can quicken their vision-building and strategy-execution efforts—the ones that can identify challenges more swiftly and accelerate their decision making so they are better able to formulate and deploy responses decisively yet with greater agility. To successfully accomplish this, companies will have to prioritize creating a culture of leadership that strengthens communication skills and emphasizes systems thinking by building capacity and capability that cuts across the business smokestacks and permeates the entire organization. In State of Readiness, Joseph F. Paris Jr. shares over thirty years of international business and operations experience and guides C-suite executives and business-operations and -improvement specialists on a path toward operational excellence, the organizational capability and situational awareness that is attained as the enterprise reaches a state of alignment for pursuing its strategies. In doing so, create a corporate culture that is committed to the continuous and deliberate improvement of company performance and the circumstances of those who work there—a precursor to becoming a high-performance organization.
Download or read book Kaizen for Pharmaceutical Medical Device and Biotech Industries written by Shruti Bhat and published by ISBN Canada. This book was released on 2017-04-05 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: 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.
Download or read book Pharmaceutical Operations Management written by Pankaj Mohan and published by McGraw-Hill Professional. This book was released on 2006-03-16 with total page 264 pages. Available in PDF, EPUB and Kindle. Book excerpt: Publisher's Note: Products purchased from Third Party sellers are not guaranteed by the publisher for quality, authenticity, or access to any online entitlements included with the product. This book brings together a winning team of international operations experts to set the framework for building a world-class manufacturing organization. Pharmaceutical Operations Management focuses on key concepts such as: Policy Execution, Risk Management, Supply chain modeling, Advance process control and Six Sigma for the pharmaceutical industry: critical techniques which will offset cost, increase efficiency and turn any manufacture into financial winner.
Download or read book Bad Pharma written by Ben Goldacre and published by Macmillan. This book was released on 2014-04 with total page 479 pages. Available in PDF, EPUB and Kindle. Book excerpt: Originally published in 2012, revised edition published in 2013, by Fourth Estate, Great Britain; Published in the United States in 2012, revised edition also, by Faber and Faber, Inc.
Download or read book Introduction to Biomanufacturing written by Northeast Biomanufacturing Center & Collaborative and published by . This book was released on 2012-11-03 with total page 510 pages. Available in PDF, EPUB and Kindle. Book excerpt: Today is a time of unparalleled excitement in the world of biopharmaceuticals. This book is a compendium of a tremendous body of knowledge, distilled into its most essential parts. Not only are there theoretical and conceptual ideas about biopharmaceutical manufacturing, but also content specific to skills and abilities. It serves as a well-paced guide for beginning learners as well as a cogent reference for seasoned biotechnology professionals alike. This book will help a new generation of students to become inspired and familiarize themselves with the theories, principles, and vernacular of biopharmaceutical production and all that it entails. A quick overview of contents include; Operational Excellence, Facilities, Metrology, Validation, Environmental Health & Safety (EHS), Quality Assurance, Microbiological Control, Quality Control Biochemistry, Upstream Processing, Downstream Processing, Process Development, and a Master Glossary.
Download or read book Redefining Operational Excellence written by Andrew Miller and published by AMACOM. This book was released on 2014-06-11 with total page 267 pages. Available in PDF, EPUB and Kindle. Book excerpt: Discover new strategies for maximizing performance and profit across your organization through the concept of operational excellence. Companies must learn that you cannot fire and budget-slice your way to sustainable growth. Our world is too complex, too interconnected, and technology too quick-evolving for organizations to achieve dramatic results simply by eliminating waste and increasing standardization. Maybe these methods worked before--occasionally--but not anymore. Redefining Operational Excellence boldly claims that the old ways of hunkering down and refocusing the business strategies are no longer viable. Operational excellence is about a mindset, and a company culture that questions current models and focuses not on slashing and subtracting but on adding value, making improvements, and increasing speed. This groundbreaking guide covers it all--processes, people, and operations--and shares specific strategies to: Drive innovation and collaboration Engage customers Attract and retain top people Align strategy and execution Optimize speed Operational excellence is about finding money and performance boosts in hidden areas businesses don't normally look. With this indispensable, all-encompassing resource, you’ll discover where!
