Sterile Product Facility Design and Project Management
Seiten
2004
|
2nd edition
Crc Press Inc (Verlag)
978-0-8493-1874-0 (ISBN)
Crc Press Inc (Verlag)
978-0-8493-1874-0 (ISBN)
Offers guidance on how to develop and execute biotech facilities projects based on industry practices. Breaking the project life-cycle process into four phases: formation, design, execution, and implementation, this text shows various phases from the Project Manager's viewpoint. It describes technical issues, with many illustrations and diagrams.
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.
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.
Odum, Jeffrey N.
Introduction to Facility Project Management Project Formation Defining the Project Team Facility Programming Project Control Current Good Manufacturing Practice (cGMP): Project Impacts Mechanical Systems GMP Compliance in Architectural Design and Construction Commissioning Quality Management to Meet Regulatory Requirements Establishment Licensing Containment Basics Multi-product Facilities for Biologics Contract Formulation and Philosophy Future Trends
| Erscheint lt. Verlag | 29.3.2004 |
|---|---|
| Verlagsort | Bosa Roca |
| Sprache | englisch |
| Maße | 156 x 234 mm |
| Gewicht | 1500 g |
| Themenwelt | Technik |
| ISBN-10 | 0-8493-1874-2 / 0849318742 |
| ISBN-13 | 978-0-8493-1874-0 / 9780849318740 |
| Zustand | Neuware |
| Haben Sie eine Frage zum Produkt? |
Mehr entdecken
aus dem Bereich
aus dem Bereich
Lern- und Arbeitsbuch (mit digitalem Training zum Downloaden)
Buch (2024)
SecuMedia (Verlag)
CHF 43,95
Praxiswissen zu Schimmelpilzschäden in Gebäuden: Mikrobiologie, …
Buch | Hardcover (2024)
Reguvis Fachmedien (Verlag)
CHF 138,60
