PMI New Jersey Chapter
IS-SIG 2003 December Meeting

10 December 2003 - AlphaNet Learning Solutions

PDP Information

Program Number: C020-10122003
Computer Systems Validation in the Pharmaceutical Industry: A Growing and Profitable Field
Category Type: 3 
Subject Areas 
Knowledge: 10 
Process: 06
Application/Specific Interest Groups: 09 
Activity Sponsor: PMINJ IS/SIG
PDUs: - 1.0
Leadership - 0.0
Strategic - 0.0
Technical - 1.0


Computer systems used in the pharmaceutical industry must be validated.  This means that "documented evidence must be produced to show that the system does what it was specified to do".  In other words, the FDA mandates that software quality assurance activities take place.  What does all this mean and how can you get involved?  Bruce Fieggen has been managing projects in this field for the last two years and presented a layman's version of what this industry is all about and the trends forecasting its growth.



Bruce Fieggen, PMP, Director of Project Management, CSSC, Inc.


Bruce Fieggen is the Director of Project Management at CSSC, a validation-consulting firm servicing the medical device and pharmaceutical industries.  In his seventeen years with seven medical device and pharmaceutical companies, he has managed projects from $100,000 validations to $10,000,000 new product developments.  He has trained and mentored dozens of project managers with specific tools using a formal 24-week ProgressixSM project management curriculum, 13-week Boston University evening project management certificate program and two-day CadenceTM project management course.  He has successfully introduced project management methodologies to medical device and pharmaceutical clients to improve ownership in tasks.  Bruce has been a certified Project Management Professional since 1999.

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