Odum Sterile Product Facility Design and Project Management, Second Edition

2. Auflage 2010
ISBN: 978-1-4200-2585-9
Verlag: Taylor & Francis
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 392 Seiten

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.

Zielgruppe

Project Engineers, Quality Managers, Project Managers, Project Directors, Facilities Engineers, Engineering Managers, Design Engineers, and Managers of Technical Services in pharmaceutical and biotechnology operating companies, and industry consultants.

Autoren/Hrsg.

Odum, Jeffrey N.

Fachgebiete

• Technische Wissenschaften Verfahrenstechnik | Chemieingenieurwesen | Biotechnologie Biotechnologie

Inhaltsverzeichnis

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