Odum, Jeffrey N. Sterile Product Facility Design and Project Management 9780367394400

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Автор: Odum, Jeffrey N.
Название: Sterile Product Facility Design and Project Management
ISBN: 9780367394400
Издательство: Taylor&Francis
Классификация:

Медицинские лабораторные анализы и их методики

ISBN-10: 0367394405
Обложка/Формат: Paperback
Страницы: 392
Вес: 0.73 кг.
Дата издания: 20.12.2019
Язык: English
Издание: 2 ed
Размер: 234 x 156 x 21
Читательская аудитория: Tertiary education (us: college)
Основная тема: Cleaning & Sterilization
Ссылка на Издательство: Link
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Поставляется из: Европейский союз
Описание:

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 Managers 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.

Sterile Product Facility Design and Project Management, Odum, Jeffrey N.