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