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Sterile Product Facility Design And Project Management Second Edition

Author: Jeffrey N. Odum
Publisher: CRC Press
ISBN: 1420025856
Size: 45.34 MB
Format: PDF, ePub, Mobi
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Knowing how to deal with the regulatory issues, understanding the impacts of cleanliness, and recognizing the affect that poor facility layout will have on GMP spaces are only some of the issues an experienced Project Manager must focus on. Completely revised and updated, Sterile Product Facility Design and Project Management, Second Edition provides comprehensive guidance on how to develop and execute biotech and other sterile drug facilities based on current industry best practices. Each chapter highlights a specific issue centered on managing biotech facilities projects in a GMP environment. The author uses real-world examples of common industry practice to lead you through the idiosyncrasies of a biotech project in an effort to answer some of the more common, and often perplexing, questions that can stand in the way of success. You get a mini seminar on each topic covered. Breaking the project life-cycle into four phases, the text takes you through each phase from the Project Manager's viewpoint. Unlike other books that cover design, technology, and validation in general terms, this book addresses the industry specific issues that make biotech facilities so costly and difficult to deliver. It puts the pieces of the puzzle together in a manner that increases your opportunity for success.

Good Design Practices For Gmp Pharmaceutical Facilities Second Edition

Author: Terry Jacobs
Publisher: CRC Press
ISBN: 1315355027
Size: 62.92 MB
Format: PDF, Mobi
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This revised publication serves as a handy and current reference for professionals engaged in planning, designing, building, validating and maintaining modern cGMP pharmaceutical manufacturing facilities in the U.S. and internationally. The new edition expands on facility planning, with a focus on the ever-growing need to modify existing legacy facilities, and on current trends in pharmaceutical manufacturing which include strategies for sustainability and LEED building ratings. All chapters have been re-examined with a fresh outlook on current good design practices.

Sterile Drug Products

Author: Michael J. Akers
Publisher: CRC Press
ISBN: 1420020560
Size: 69.72 MB
Format: PDF, ePub
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Sterile Drug Products: Formulation, Packaging, Manufacturing, and Quality teaches the basic principles of the development and manufacture of high quality sterile dosage forms. The author has 38 years of experience in the development and manufacture of sterile dosage forms including solutions, suspensions, ophthalmics and freeze dried products. This book is based on the courses he has delivered for over three decades, to over 3000 participants, and is intended to remain relevant for the indefinite future even as new technologies and new applications of old technologies become common. This is an ideal reference book for those working directly and indirectly with sterile dosage forms, be it product development (formulation, package, process, analytical), manufacturing, quality control, quality assurance, regulatory, purchasing, or project management. This book is also intended as an educational resource for the pharmaceutical and biopharmaceutical industry and pharmacy schools, providing basic knowledge and principles in four main areas of parenteral science and technology: Product development, including formulation, packaging, and process development. Manufacturing, including basic teaching on all the primary unit operations involved in preparation of sterile products and the underlying importance of contamination control. Quality and regulatory, including the application of good manufacturing practice regulations, aseptic processing guidelines, and unique quality control testing methods for the sterile dosage form Clinical aspects, including administration, potential hazards, and biopharmaceutics of sterile products in a clinical setting.

Process Architecture In Biomanufacturing Facility Design

Author: Jeffery Odum
Publisher: John Wiley & Sons
ISBN: 1118833651
Size: 57.88 MB
Format: PDF, Kindle
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Essential information for architects, designers, engineers, equipment suppliers, and other professionals who are working in or entering the biopharmaceutical manufacturing field Biomanufacturing facilities that are designed and built today are radically different than in the past. The vital information and knowledge needed to design and construct these increasingly sophisticated biopharmaceutical manufacturing facilities is difficult to find in published literature—and it’s rarely taught in architecture or design schools. This is the first book for architects and designers that fills this void. Process Architecture in Biomanufacturing Facility Design provides information on design principles of biopharmaceutical manufacturing facilities that support emerging innovative processes and technologies, use state-of-the-art equipment, are energy efficient and sustainable, and meet regulatory requirements. Relying on their many years of hands-on design and operations experience, the authors emphasize concepts and practical approaches toward design, construction, and operation of biomanufacturing facilities, including product-process-facility relationships, closed systems and single use equipment, aseptic manufacturing considerations, design of biocontainment facility and process based laboratory, and sustainability considerations, as well as an outlook on the facility of the future. Provides guidelines for meeting licensing and regulatory requirements for biomanufacturing facilities in the U.S.A and WHO—especially in emerging global markets in India, China, Latin America, and the Asia/Pacific regions Focuses on innovative design and equipment, to speed construction and time to market, increase energy efficiency, and reduce footprint, construction and operational costs, as well as the financial risks associated with construction of a new facility prior to the approval of the manufactured products by regulatory agencies Includes many diagrams that clarify the design approach Process Architecture in Biomanufacturing Facility Design is an ideal text for professionals involved in the design of facilities for manufacturing of biopharmaceuticals and vaccines, biotechnology, and life-science industry, including architects and designers of industrial facilities, construction, equipment vendors, and mechanical engineers. It is also recommended for university instructors, advanced undergraduates, and graduate students in architecture, industrial engineering, mechanical engineering, industrial design, and industrial interior design.

Good Design Practices For Gmp Pharmaceutical Facilities

Author: Terry Jacobs
Publisher: Taylor & Francis US
ISBN: 0849398533
Size: 75.50 MB
Format: PDF
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A convenient single-source reference for anyone involved in the planning, construction, validation, and maintenance of modern pharmaceutical facilities, this guide assists project managers as they develop, diagram, and implement pharmaceutical production facility projects-demonstrating how advances in technology and external regulation can impact the production and efficacy of a pharmaceutical facility and the products it produces.

Manufacturing Of Pharmaceutical Proteins

Author: Stefan Behme
Publisher: John Wiley & Sons
ISBN: 3527683097
Size: 24.23 MB
Format: PDF, Docs
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Structured like a textbook, the second edition of this reference covers all aspects of biopharmaceutical manufacturing, including legal and regulatory issues, production facility design, and quality assurance, with a focus on supply chain management and regulations in emerging markets and cost control. The author has longstanding industrial expertise in biopharmaceutical production and years of experience teaching at universities. As such, this practical book is ideal for use in academia as well as for internal training within companies.

Project Management Case Studies

Author: Harold Kerzner
Publisher: John Wiley & Sons
ISBN: 111938916X
Size: 23.91 MB
Format: PDF, Docs
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Learn how project management can make a company sink or soar Project Management Case Studies presents a compilation of illustrative case studies showcasing both exceptional and poorly-implemented project management techniques. Broad in scope yet rich in industry-specific detail, this book provides over 100 case studies drawn from real companies to demonstrate ways in which project management concepts translate into real-world action. This new fifth edition has been updated to meet today's project management standards, and features 18 new case studies including high-profile cases from Disney, the Olympics, 787 Dreamliner, Airbus 380, and more, with new cases that specifically focus on agile and scrum methodologies. Whether you're preparing for a PMP certification, seeking continuing education, or just looking to broaden your understanding of the project management function, this book provides crystal-clear illustration of what real-world project management entails. Effective project management is the key to competitive advantage and financial success for any company. Planning, scheduling, and controlling are critical functions that can make or break an operation, and when things go wrong, the results can be catastrophic. This book takes you inside major successes and failures to show you what worked, what didn't, and what should have been done differently. Learn how project management techniques are put into real-world practice Discover how companies rely upon project managers to remain competitive Examine agile and scrum methodologies and their applications in industry Identify new practices and techniques that could benefit your organization Project management is more action than concept, making case studies the ideal way to internalize essential techniques. Whether used alone or as a supplement to any project management textbook, Project Management Case Studies provides invaluable insight and clear lessons from major companies around the world.

Sterilization Of Drugs And Devices

Author: WayneP. Olson
Publisher: Routledge
ISBN: 135141383X
Size: 78.88 MB
Format: PDF, Mobi
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Editors Fred M. Nordhauser and Wayne P. Olson have gathered a team of 18 experts from multi-national and leading edge companies to explore the advantages and disadvantages of current sterilization technologies. They cover the theory behind the technology, the practical concerns of installation from engineering and product development perspectives, the ""how to validate"" concern, and the pragmatics of implementation in a manner that will satisfy the regulatory agencies. The broad range of in-depth information on numerous technologies will help readers design sterile manufacturing processes cost effectively and efficiently.