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June 12, 2007  

 
Time 5:30 - 8:30PM
 
Location Doubletree Hotel Boston/Westborough
5400 Computer Drive
Westboro, MA 01581
Tel: 508-366-5511
 
Meeting Sponsor EagleWing Consulting
 
Guest Speaker Bruce Kozuma, PMP
 
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
 
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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