By Jeffrey N. Odum

The writer examines key venture administration actions as they relate to the layout and building of sterile amenities for biotech or different reasons. Chapters examine criminal and technical matters, delivering chapters on undertaking keep watch over, present perform within the undefined, mechanical platforms, architectural layout and development, caliber administration, regulatory standards, and different themes.

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Additional info for Sterile Product Facility Design and Project Management, Second Edition

Example text

Pilot Plant Expansion Project Your firm is invited to submit a proposal to provide design and engineering services to ABC Biotech and to assist in the construction and commissioning of a pilot plant expansion project, to be located in Anywhere, USA. Your firm, along with others, has been selected for this invitation because of your reputation, experience, and qualifications in the biotech industry. The following information is being provided as the basis for the preparation of your proposal: 1.

When additional criteria must be considered (I believe there is always more to a decision than money), each criterion should be evaluated using tools that address risk, project needs criteria, and the potential range of outcomes. fm Page 31 Thursday, February 5, 2004 9:04 AM Chapter 2: Project formation 31 We have found that using identified criteria developed by the project team and assigning weights to each criterion provides a systematic approach. Every criterion will not carry the same level of importance or confidence.

It is important that the project WBS reflect the project scope of work and facilities. fm Page 36 Thursday, February 5, 2004 9:04 AM 36 Sterile Product Facility Design and Project Management The WBS is then used to divide the project work elements into a finer level of detail for control. A work package matrix can then be developed for each WBS area. These packages will be used to schedule engineering design work to support construction contract releases. The packages are based on the timing of design release, contracting philosophy, cost efficiencies, and so on.

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