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EBookClubs

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Book When Worlds Collide in Manufacturing Operations

Download or read book When Worlds Collide in Manufacturing Operations written by Charlie Gifford and published by ISA. This book was released on 2011 with total page 285 pages. Available in PDF, EPUB and Kindle. Book excerpt: Book 2.0 is the second collection of public methodology white papers from the ISA-95/MESA Best Practices Working Group. The methodology white papers focus on applying the ISA-95 standards to accelerate the adoption of Manufacturing Operations Management (MOM) systems and the Manufacturing 2.0 Architecture (Mfg 2.0) approach.

Book The FDA and Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals

Download or read book The FDA and Worldwide Current Good Manufacturing Practices and Quality System Requirements Guidebook for Finished Pharmaceuticals written by José Rodríguez-Pérez and published by Quality Press. This book was released on 2014-08-15 with total page 246 pages. Available in PDF, EPUB and Kindle. Book excerpt: This guidance book is meant as a resource to manufacturers of pharmaceuticals, providing up-to-date information concerning required and recommended quality system practices. It should be used as a companion to the regulations/standards themselves and texts on the specific processes and activities contained within the QMS. This book includes chapters on US current Good Manufacturing Practice (GMP); international GMP; global GMP guides and harmonization; detailed analysis of the requirements and guidances; missing subparts; what inspectors are looking for; and the price of noncompliance. It also includes an appendix with two tabulated comparisons: the first compares US, European-PIC/S, Canadian, and WHO cGMPs, while the second compares US cGMPs with effective quality system elements. The companion CD contains cGMP regulations for sterile products produced by aseptic processing; it also includes updated data of statistical enforcement by the FDA, both domestically and abroad; a detailed glossary; and dozens of FDA guidance documents as well as international regulations (EU and Canada) and harmonization documents (WHO, PIC/S, and ICH). A very comprehensive checklist for a cGMP audit that is based on risk management criteria is also included. Finally, a comprehensive GMP exam is also included.

Book Good Clinical  Laboratory and Manufacturing Practices

Download or read book Good Clinical Laboratory and Manufacturing Practices written by Philip Carson and published by Royal Society of Chemistry. This book was released on 2007-10-31 with total page 657 pages. Available in PDF, EPUB and Kindle. Book excerpt: Quality assurance and good laboratory practices are becoming essential knowledge for professionals in all sorts of industries. This includes internal and external audit procedures for compliance with the requirements of good clinical, laboratory and manufacturing practices. Spanning chemical, cosmetic and manufacturing industries, Good Clinical, Laboratory and Manufacturing Practices: Techniques for the QA professional is aimed at: chemists, clinicians, ecotoxicologists, operation managers, pharmaceutical process managers, quality assurance officers, technicians and toxicologists. In addition sections on harmonisation of quality systems will be of value to safety, health and environment advisors. This comprehensive and high level reference will be an indispensable guide to research laboratories in academia and industry. Additional training material is also included.

Book High Performance Manufacturing

Download or read book High Performance Manufacturing written by Roger G. Schroeder and published by John Wiley & Sons. This book was released on 2002-03-14 with total page 321 pages. Available in PDF, EPUB and Kindle. Book excerpt: The most thorough, valid set of findings on global manufacturing and winning practices worldwide This eye-opening resource sets a new standard for how manufacturing practices are viewed in today's business world. The results of an extensive research project spanning 164 factories in the United States, Japan, Germany, Italy, and the United Kingdom determine the best path to high performance manufacturing. This is one of the first books to offer comparisons of manufacturing in these five countries, addressing their current issues and providing insights that affect manufacturing worldwide. Researchers from such universities as the London Business School, Wake Forest University, Yokohama University, and the University of Minnesota detail how manufacturing leaders are raising the bar on practices in product development, organizational alignment, quality management, and more. Covering the vital areas of machinery, electronics, and auto components, they examine the most effective methods and techniques across a host of functions within manufacturing-looking at how everything from new technology and information systems to human resource practices and manufacturing strategy should be introduced into a plant environment to achieve high performance manufacturing. Using data from companies such as Texas Instruments, Honda, Sony, Prince, John Deere, and Caterpillar, High Performance Manufacturing takes a comprehensive view by showing how to select and integrate the practices that best fit a plant's particular situation-the most critical and difficult task to achieve in practice. With its strong research base and high caliber of contributors, this unique volume will inspire managers of any country or industry to set their own path to high performance manufacturing.

Book Best Practices in Manufacturing Processes

Download or read book Best Practices in Manufacturing Processes written by Jorge Luis García Alcaraz and published by Springer. This book was released on 2018-09-18 with total page 558 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book reports the best practices that companies established in Latin America are implementing in their manufacturing processes in order to generate high quality products and stay in the market. It lists the technologies, production and administrative philosophies that are being implemented, presenting a collection of successful cases of studies from Latin America. The book describes how the tools and techniques are being integrated, modified and combined to create new technical resources for assisting the decision making process for better economic performance in manufacturing companies. The efforts deployed for assisting the transformation of raw materials into products and services are described. The authors explain the main key success factors or drivers for success of each tool, technique or hybrid combination approach applied to solve manufacturing problems.

Book Food and Drink   Good Manufacturing Practice

Download or read book Food and Drink Good Manufacturing Practice written by Institute of Food Science and Technology and published by John Wiley & Sons. This book was released on 2018-10-22 with total page 389 pages. Available in PDF, EPUB and Kindle. Book excerpt: The latest updated edition of the market-leading guide to Good Manufacturing Practice (GMP) in the food and drink industry This all-new, 7th edition of Food and Drink - Good Manufacturing Practice: A Guide to its Responsible Management features a wealth of new information reflecting changes in the industry and advances in science that have occurred since the publication of the last edition back in 2013. They include topics such as: Food Safety Culture, Food Crime and Food Integrity Management Systems, Food Crime Risk Assessment including vulnerability risk assessment and Threat Analysis Critical Control Point (TACCP), Security and Countermeasures, Food Toxins, Allergens and Risk Assessment, Provenance and authenticity, Electronic and digital traceability technologies, Worker Welfare Standards; Smart Packaging, Food Donation Controls and Animal Food Supply, Safety Culture; Provenance and integrity testing and Sustainability Issues. In addition to the new topics mentioned above, Food and Drink - Good Manufacturing Practice, 7th Edition offers comprehensive coverage of information in chapters on Quality Management System; Hazard Analysis Critical Control Point (HACCP); Premises and Equipment; Cleaning and Sanitation; Product Control, Testing and Inspection; Heat Preserved Foods; Frozen Foods; Foods for Catering and Vending Operations; and much more. Comprises both general guidance and food sector-specific requirements for good manufacturing practice Incorporates all the most recent developments and changes in UK and EU law Provides a readable and accessible reference for busy managers in the food industry Food and Drink - Good Manufacturing Practice: A Guide to its Responsible Management, 7th Edition is a valuable reference for anyone in a managerial or technical capacity concerned with the manufacture, storage, and distribution of food and drink. The book is also a “must –read” for the recommended reading lists for food science, food technology and food policy undergraduate and postgraduate studies. IFST - the Institute of Food Science and Technology is the leading qualifying body for food professionals in Europe and the only professional qualifying body in the UK concerned with all aspects of food science and technology.

Book Manufacturing Handbook of Best Practices

Download or read book Manufacturing Handbook of Best Practices written by Jack B. ReVelle and published by CRC Press. This book was released on 2001-12-26 with total page 472 pages. Available in PDF, EPUB and Kindle. Book excerpt: Manufacturing Handbook of Best Practices: An Innovation, Productivity, and Quality Focus gives you a working knowledge of today's cutting edge tools - preparing you for the way you will be doing your job tomorrow. With contributions from seasoned manufacturing experts, the book provides a single-source reference to what's currently happening in mod

Book Good Quality Practice  GQP  in Pharmaceutical Manufacturing  A Handbook

Download or read book Good Quality Practice GQP in Pharmaceutical Manufacturing A Handbook written by Jordi Botet and published by Bentham Science Publishers. This book was released on 2015-09-28 with total page 504 pages. Available in PDF, EPUB and Kindle. Book excerpt: Pharmaceutical manufacturing can be viewed as a supply chain which spans from the production and purchase of the starting and packaging materials through the manufacture of dosage forms until the safe reception of the finished product by the patient. The entire chain comprises of several processes: auditing, materials purchase (procurement), production, storage, distribution, quality control, and quality assurance. The quality standard for pharmaceutical production is ‘current good manufacturing practice (CGMP)’‘, which is applied within the frame of a pharmaceutical quality system (PQS). This implementation, however, requires a scientific approach and has to take into account several elements such as risk assessment, life cycle, patient protection, among other factors. Hence, pharmaceutical manufacturing is a complex subject in terms of regulation, given the technical and managerial requirements. This comprehensive handbook describes CGMP for new professionals who want to understand and apply the elements which build up pharmaceutical quality assurance. The book gives details about basic quality control requirements (such as risk management, quality hazards and management systems, documentation, clean environments, personnel training) and gives guidelines on regulatory aspects. This is an ideal handbook for undergraduates studying pharmaceutical or industrial manufacturing and supply chains as well for entrepreneurs and quality control professionals seeking to learn about CGMP standards and implementing quality assurance systems in the pharmaceutical sector.

Book Worldwide Good Manufacturing Practices

Download or read book Worldwide Good Manufacturing Practices written by and published by . This book was released on 1993 with total page 406 pages. Available in PDF, EPUB and Kindle. Book excerpt:

Book Manufacturing Best Practices

Download or read book Manufacturing Best Practices written by Bobby Hull and published by John Wiley & Sons. This book was released on 2010-10-12 with total page 241 pages. Available in PDF, EPUB and Kindle. Book excerpt: World-class tools for businesses to create their own manufacturing best practices Providing best practices used throughout the manufacturing sector, Manufacturing Best Practices takes currently available manufacturing tools, such as six Sigma, Lean, ISO and Statistical Process Control (SPC), combined with real world experience, and shows how they can be used to create a culture or philosophy within an organization. Shows that it is not the tools that make best practices, but rather the mindset that can be developed through the use of the tools Provides best practices for manufacturers to pick those that are most applicable to their needs Written for CEOs, CFOs, controllers, and line managers in the manufacturing sector Manufacturing Best Practices closely examines the processes, protocols, and philosophies that are used in manufacturing so companies can create their own best practices scenario.

Book Manufacturing Processes for Design Professionals

Download or read book Manufacturing Processes for Design Professionals written by Rob Thompson and published by Thames & Hudson. This book was released on 2007-11-30 with total page 528 pages. Available in PDF, EPUB and Kindle. Book excerpt: An encyclopaedic guide to production techniques and materials for product and industrial designers, engineers, and architects. Today's product designers are presented with a myriad of choices when creating their work and preparing it for manufacture. They have to be knowledgeable about a vast repertoire of processes, ranging from what used to be known as traditional "crafts" to the latest technology, to enable their designs to be manufactured effectively and efficiently. Information on the internet about such processes is often unreliable, and search engines do not usefully organize material for designers. This fundamental new resource explores innovative production techniques and materials that are having an impact on the design industry worldwide. Organized into four easily referenced parts—Forming, Cutting, Joining, and Finishing—over seventy manufacturing processes are explained in depth with full technical descriptions; analyses of the typical applications, design opportunities, and considerations each process offers; and information on cost, speed, and environmental impact. The accompanying step-by-step case studies look at a product or component being manufactured at a leading international supplier. A directory of more than fifty materials includes a detailed technical profile, images of typical applications and finishes, and an overview of each material's design characteristics. With some 1,200 color photographs and technical illustrations, specially commissioned for this book, this is the definitive reference for product designers, 3D designers, engineers, and architects who need a convenient, highly accessible, and practical reference.

Book The 12 Principles of Manufacturing Excellence

Download or read book The 12 Principles of Manufacturing Excellence written by Larry E. Fast and published by CRC Press. This book was released on 2011-09-20 with total page 268 pages. Available in PDF, EPUB and Kindle. Book excerpt: Explaining how to implement and sustain a top-down strategy for manufacturing excellence, The 12 Principles of Manufacturing Excellence: A Leader’s Guide to Achieving and Sustaining Excellence provides a comprehensive, proven approach for delivering world-class performance while also cultivating the right culture through leadership and mentoring. Tapping into four decades of leadership experience, 35 years of it in the manufacturing industry, Larry Fast explains how to achieve vertical and horizontal alignment across your organization. He details a clear pathway to excellence via the 12 Principles of Manufacturing Excellence and provides a method for tracking progress—plant by plant and function by function. Emphasizing the importance of using Lean and Six Sigma tools to improve your business, the book: Integrates strategy and leadership development Paves a path for culture change–Operator-Led Process Control (OLPC)—that prepares hourly employees to take control of their processes and prepares management to enable them to do it Details an audit process for tracking progress and ensuring sustainability Includes a CD with color versions of the images in the book as well as a sample Manufacturing Excellence Audit, a sample Communications Plan, and a sample Training Plan that can all be easily customized for the reader’s use This resource-rich book will allow you to spell out leadership expectations and provide your employees and associates with a clear understanding of their individual roles. Helping you keep everyone in your organization focused during the quest towards sustainable manufacturing excellence, the accompanying CD supplies the tools you and your team will need to pursue it with passion, confidence, and urgency. Listen to what Larry Fast has to say about his new book, The 12 Principles of Manufacturing Excellence. Part One — Part Two

Book Good Manufacturing Practices for Pharmaceuticals

Download or read book Good Manufacturing Practices for Pharmaceuticals written by Joseph D. Nally and published by CRC Press. This book was released on 2016-04-19 with total page 418 pages. Available in PDF, EPUB and Kindle. Book excerpt: With global harmonization of regulatory requirements and quality standards and national and global business consolidations ongoing at a fast pace, pharmaceutical manufacturers, suppliers, contractors, and distributors are impacted by continual change. Offering a wide assortment of policy and guidance document references and interpretations, this Sixth Edition is significantly expanded to reflect the increase of information and changing practices in CGMP regulation and pharmaceutical manufacturing and control practices worldwide. An essential companion for every pharmaceutical professional, this guide is updated and expanded by a team of industry experts, each member with extensive experience in industry or academic settings.

Book Good Manufacturing Practices for Pharmaceuticals  Seventh Edition

Download or read book Good Manufacturing Practices for Pharmaceuticals Seventh Edition written by Graham P. Bunn and published by CRC Press. This book was released on 2019-02-04 with total page 387 pages. Available in PDF, EPUB and Kindle. Book excerpt: This book provides insight into the world of pharmaceutical quality systems and the key elements that must be in place to change the business and organizational dynamics from task-oriented procedure-based cultures to truly integrated quality business systems that are self-detecting and correcting. Chapter flow has been changed to adopt a quality systems organization approach, and supporting chapters have been updated based on current hot topics including the impact of the worldwide supply chain complexity and current regulatory trends. Key Features: Presents insight into the world of pharmaceutical quality systems Analyzes regulatory trends and expectations Includes approaches and practices used in the industry to comply with regulatory requirements Discusses recent worldwide supply chain issues Delivers valuable information to a worldwide audience regarding the current GMP practices in the industry

Book Manufacturing Systems

Download or read book Manufacturing Systems written by National Academy of Engineering and published by National Academies Press. This book was released on 1992-02-01 with total page 282 pages. Available in PDF, EPUB and Kindle. Book excerpt: Some 70 percent of U.S. manufacturing output currently faces direct foreign competition. While American firms understand the individual components of their manufacturing processes, they must begin to work with manufacturing systems to develop world-class capabilities. This new book identifies principles-termed foundations-that have proved effective in improving manufacturing systems. Authored by an expert panel, including manufacturing executives, the book provides recommendations for manufacturers, leading to specific action in three areas: Management philosophy and practice. Methods used to measure and predict the performance of systems. Organizational learning and improving system performance through technology. The volume includes in-depth studies of several key issues in manufacturing, including employee involvement and empowerment, using learning curves to improve quality, measuring performance against that of the competition, focusing on customer satisfaction, and factory modernization. It includes a unique paper on jazz music as a metaphor for participative manufacturing management. Executives, managers, engineers, researchers, faculty, and students will find this book an essential tool for guiding this nation's businesses toward developing more competitive manufacturing systems.

Book Unveiling the Secrets of Good Manufacturing Practices

Download or read book Unveiling the Secrets of Good Manufacturing Practices written by Dr. Akash Sharma, Vriti Gamta, Gaurav Luthra and published by Notion Press. This book was released on 2023-09-13 with total page 76 pages. Available in PDF, EPUB and Kindle. Book excerpt: "Unveiling the Secrets of Good Manufacturing Practices: Building Excellence in Healthcare Manufacturing" is a comprehensive guide that unlocks the secrets to achieving manufacturing excellence through the implementation of Good Manufacturing Practices (GMP). This book provides valuable insights and practical strategies for navigating the complexities of GMP, ensuring product quality, regulatory compliance, and customer satisfaction. From facility design and documentation control to supplier management, process validation, and continuous improvement, each chapter explores key principles, real-world case studies, and best practices. Whether you're a quality manager, production supervisor, or involved in GMP compliance, this book equips you with the knowledge and tools to build a culture of excellence in manufacturing. Unveil the secrets of GMP and elevate your manufacturing operations to new heights of success.