2nd Edition

Sterile Product Facility Design and Project Management

By Jeffrey N. Odum Copyright 2004
390 Pages
by CRC Press

390 Pages
by CRC Press

392 Pages
by CRC Press

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... Read more
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

Biography

Odum, Jeffrey N.