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June 12, 2007
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| Time |
5:30 - 8:30PM |
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| Location |
Doubletree Hotel Boston/Westborough
5400 Computer Drive
Westboro, MA 01581
Tel: 508-366-5511 |
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| Meeting Sponsor |
EagleWing Consulting |
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| Guest Speaker |
Bruce Kozuma, PMP |
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| Topic |
Case Study of IT-focused Project Management in a Biopharmaceutical Manufacturing Environment
Synopsis:
* Drivers of Project Management in a biopharmaceutical manufacturing
environment are different from the usual cost, schedule, and resources
constraints. Overriding concerns are the following:
- Compliance with regulations/standards (e.g., cGMP, CFR 21 Part 11, SOX)
- Supply of product to patients
* The presentation will focus on the following topics of particular
interest to PMI members:
- Overview of the project to support a biopharmaceutical manufacturing
environment
- Different definitions of Quality between PMBOK and a typical cGMP
environment
- Career skills necessary for Project Managers to break into and thrive
in such an environment
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| About the Speaker |
Bruce Kozuma, PMP
is a member of the Mass Bay PMI chapter. He is the Manager of the Project
Management group within Biotech Information Services department for the
Andover/Wilmington sites of Wyeth Biotech (Technical Operations and Product
Supply), a division of Wyeth Pharmeceuticals. Bruce has background in
fields such as Physics, Technical Writing, Software Development, and
implementation/support of systems such as ERP, MES, PDM, and QMS.
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