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Leading Pharmaceutical Operational Excellence by Thomas Friedli,Prabir Basu,Daniel Bellm,Jürgen Werani Pdf
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.
Operational Excellence in the Pharmaceutical Industry by Daniel Bellm Pdf
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.
The Pathway to Operational Excellence in the Pharmaceutical Industry by Thomas Friedli Pdf
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.
Operational Excellence in the Pharmaceutical Industry by Thomas Friedli,Bart Bastoen Pdf
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).
A Lifecycle Approach to Knowledge Excellence in the Biopharmaceutical Industry by Nuala Calnan,Martin J Lipa,Paige E. Kane,Jose C. Menezes Pdf
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.
Redefining Operational Excellence by Andrew Miller Pdf
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!
Author : Joseph F. Paris Jr. Publisher : Greenleaf Book Group Page : 400 pages File Size : 50,7 Mb Release : 2017-05-16 Category : Business & Economics ISBN : 9781626343122
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.
Global Manufacturing Management by Thomas Friedli,Gisela Lanza,Dominik Remling Pdf
Using site-specific optimization approaches in international manufacturing networks is increasingly proving insufficient. To solve this problem, several holistic and integrated alternatives have been developed to reflect a global perspective. This book presents advances in the St. Gallen Global Manufacturing Network Model and its application in numerous industry-, benchmarking- and research projects. The contents combine data-driven solutions with qualitative management frameworks for the strategic optimization of international manufacturing networks. In the first part, the book addresses the foundation of manufacturing network management and further describes the St. Gallen Operational Excellence approaches to manage plant performance. On this basis, the authors show how plant- and network-level performance can be enhanced via key improvement domains (e.g., strategy, configuration, coordination, performance management, digitalization). In turn, the second part demonstrates the application of the constructs in manufacturing companies from various industries. By combining research and practice, the book offers unique perspectives on the management of global production striving toward higher performance on manufacturing site and network level.
Kaizen for Pharmaceutical, Medical Device and Biotech Industries by Shruti Bhat Pdf
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.
The Discipline of Market Leaders by Michael Treacy,Fred Wiersema Pdf
Why is it that Casio can sell a calculator more cheaply than Kellogg's can sell a box of corn flakes? Why can FedEx “absolutely, positively” deliver your package overnight but airlines have trouble keeping track of your bags? What does your company do better than anyone else? What unique value do you provide to your customers? How will you increase that value next year? As customers' demands for the highest quality products, best services, and lowest prices increase daily, the rules for market leadership are changing. Once powerful companies that haven't gotten the message are faltering, while others, new and old, are thriving. In disarmingly simple and provocative terms, Treacy and Wiersema show what it takes to become a leader in your market, and stay there, in an ever more sophisticated and demanding world.
WCOM (World Class Operations Management) by Carlo Baroncelli,Noela Ballerio Pdf
This book deals with World Class Operations Management (WCOM), detailing its principles, methods and organisation, and the results that this approach can bring about. Utilising real-world case studies illustrated by companies that have adopted this model (interviews with Saint-Gobain, L’Oréal, Tetra Pak, Bemis, and Bel Executives), it describes common patterns drawn from decades of hands-on experience, so as to present a theoretical approach together with the concrete application of its principles. WCOM, adopted by several multinational companies, is one of the more innovative management practises, as it integrates the best Continuous Improvement approaches (Lean, Total Productive Management, World Class Manufacturing) as well as the most innovative approaches in human dynamics like Change Leadership, Performance Behavior, Shingo Model, to name a few. Every book’s chapter has been authored by an expert in these different fields, thus revealing the synergy among the different practices, which is one of the distinguishing and successful aspects of WCOM Maximising reader insights into the successful implementation of such an approach, and explaining not only its potentialities, but also its implementation dynamics, the critical points and the ways it can be integrated into different situations, this book is also about how to create a culture of excellence that is sustainable over a long period of time and delivers consistent (or ever-improving) results.
The Handbook for Quality Management, Second Edition by Thomas Pyzdek,Paul A. Keller Pdf
The definitive guide to organizational excellence--completely updated Fully revised for the latest American Society for Quality (ASQ) Certified Manager of Quality/Organizational Excellence (CMQ/QE) Body of Knowledge, The Handbook for Quality Management: A Complete Guide to Operational Excellence, Second Edition offers in-depth guidance on effectively applying the principles of quality management in today's business environment and delivering superior results. Designed to help you prepare for and pass the ASQ CMQ/QE exam, this authoritative volume also serves as an essential on-the-job reference. Coverage includes: Business-integrated quality systems Organizational structures The quality function Approaches to quality Customer-focused organizations Integrated planning Strategic planning Understanding customer expectations and needs Benchmarking Organizational assessment Process control Quantifying process variation Quality audits Supply chain management Continuous improvement Effective change management Six Sigma methodology, including detailed descriptions of the DMAIC and DMADV approaches Management of human resources Motivation theories and principles Management styles Resource requirements to manage the quality function Over the past 40 years, the quality management discipline has undergone steady evolution from disparate quality assurance efforts to strategic, business-integrated functions. Today's quality manager must be able to plan and implement measurable, cost-effective process-improvement initiatives across the organization. Written by two of the foremost authorities on the subject and fully updated for the latest American Society for Quality (ASQ) Certified Manager of Quality/Organizational Excellence (CMQ/OE) Body of Knowledge, The Handbook for Quality Management, Second Edition provides an operational guide to the proper understanding and application of quality management in the current business environment. It serves as a primary reference source for an organization's quality program and for anyone seeking to pass the CMQ/OE exam, given by the ASQ. The Handbook for Quality Management: A Complete Guide to Operational Excellence, Second Edition: Clearly defines quality management principles and their application within a cross section of industries Integrates the application of Theory of Constraints, Six Sigma, and Lean thinking into the Quality Management discipline Contains detailed methods for planning, including customer needs recognition, benchmarking, and organizational assessments Discusses controls such as statistical process control, audits, and supply chain management Explains the stages of continuous improvement Incorporates classic motivation theory with more current management practices advocated by Joiner, Senge, and Deming, among others Features simulated and past exam questions to help you study for the ASQ CMQ/OE exam with answers that can be found at www.mhprofessional.com/HQM2
Lars Schweizer,Theodor Dingermann,Otto Quintus Russe
Author : Lars Schweizer,Theodor Dingermann,Otto Quintus Russe Publisher : Saint Philip Street Press Page : 0 pages File Size : 46,9 Mb Release : 2020-10-09 Category : Medical ISBN : 1013277783
Advances in Pharma Business Management and Research by Lars Schweizer,Theodor Dingermann,Otto Quintus Russe Pdf
This open access book presents a unique collection of practical examples from the field of pharma business management and research. It covers a wide range of topics such as: 'Brexit and its Impact on pharmaceutical Law - Implications for Global Pharma Companies', 'Implementation of Measures and Sustainable Actions to Improve Employee's Engagement', 'Global Medical Clinical and Regulatory Affairs (GMCRA)', and 'A Quality Management System for R&D Project and Portfolio Management in a Pharmaceutical Company'. The chapters are summaries of master's theses by "high potential" Pharma MBA students from the Goethe Business School, Frankfurt/Main, Germany, with 8-10 years of work experience and are based on scientific know-how and real-world experience. The authors applied their interdisciplinary knowledge gained in 22 months of studies in the MBA program to selected practical themes drawn from their daily business. This work was published by Saint Philip Street Press pursuant to a Creative Commons license permitting commercial use. All rights not granted by the work's license are retained by the author or authors.
Applying Lean Six Sigma in the Pharmaceutical Industry by Bikash Chatterjee Pdf
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.
Argues that doctors are deliberately misinformed by profit-seeking pharmaceutical companies that casually withhold information about drug efficacy and side effects, explaining the process of pharmaceutical data manipulation and its global consequences. By the best-selling author of Bad Science.
