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PMINJ 2002 March Meeting

19 March 2002 - Hanover - Manor


PDP Information

Program Number: C020-19032002
Challenges of Successful Project Management in a Regulated Environment
Category Type: 3 
Subject Areas 
Knowledge: 08 
Process: 06
Application/Specific Interest Groups: 30 
Activity Sponsor: PMINJ Chapter (C020)
PDUs: - 1.5
Leadership - 0.0
Strategic - 0.0
Technical - 1.5


Project Management - part art, part science.  At its best, project management is difficult but rewarding.  (How much work goes into completing a major project on time and on budget?)  At its worst, project management can be a frustrating sequence of near-disasters, ranging from under-performing consultants to exasperated users, changing requirements and unforeseen delays.  In this context: 
  • Does a regulated environment help ensure better project management?
  • Or, does working in a regulated environment actually hinder your ability to manage projects effectively?
Lucy Kramer discussed some of the unique challenges of successful project management in a regulated environment.  These included: extensive quality assurance, testing and documentation requirements, elongated document and software and hardware retention schedules, and the special considerations of a FDA inspection. 

Ms. Kramer also probed some of the similarities and differences between IT project management in the pharmaceutical industry and the telecommunications


  Lucy Kramer - Schering Plough 

Ms. Kramer is Associate Director, Systems Assurance and Planning at Schjering-Plough Corporation. 

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