17Oct2012
March 19, 2002 Hanover Manor
Challenges of Successful Project Management in a Regulated Environment

PDP Information:
Program Number: C020-19032002 
Program Title: "Challenges of Successful Project Management in a Regulated Environment" 
PDUs: 1.5 
Category Type: 3 
Subject Areas 
Knowledge: 08 
Process: 06 
Application/Specific Interest Groups: Pharmaceutical
Activity Sponsor: NJ/PMI Chapter
Lucy Kramer - Schering Plough 

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
sector. 

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

Lucy's view graphs can be downloaded.

Updated: 09Jun09