Sterile Product Facility Design and Project Management

Jeffrey N. Odum

$131

Paperback

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English

CRC Press
07 October 2019

Medical laboratory testing & techniques

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.

By: Jeffrey N. Odum
Imprint: CRC Press
Country of Publication: United Kingdom
Edition: 2nd edition
Dimensions: Height: 234mm, Width: 156mm,
Weight: 453g
ISBN: 9780367394400
ISBN 10: 0367394405
Pages: 390
Publication Date: 07 October 2019
Audience: Professional and scholarly , Undergraduate
Format: Paperback
Publisher's Status: Active

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

Odum, Jeffrey N.

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Sterile Product Facility Design and Project Management

Jeffrey N. Odum

$131

Paperback

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