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What our members say

For many years I have spent my own time lecturing at colleges and speaking at seminars. I just love it. I think that the minute one stops learning, one stops living.

Gopal Nair, CEO
GRASP Enterprise, India

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True Stories: What it means to be an ISPE Member - (WMV, 16 MB) (Click to begin, or right-click to download and view later)

About ISPE
Academic Affiliations

BioNetwork

ISPE has entered into a License Agreement with the North Carolina Community College System for the development of the BioNetwork Validation Service Academy. The North Carolina Community College BioNetwork Validation Academy is a partnership between BioNetwork, ISPE, and the Department of Commerce.
 
The academy will be a major attraction for new companies wishing to open pharmaceutical or biomanufacturing facilities in North Carolina, and for growing companies as well that are planning facility expansions.

ISPE Director of Professional Certification Jerry Roth says that the partnership with BioNetwork is unique, and a first for the international organization. The partnership was approved at ISPE's international board meeting in Berlin in October 2004.

Validation is a regulatory requirement for biopharmaceutical facilities. Validation is the written proof a pharmaceutical or biomanufacturer must be able to provide to demonstrate with a high degree of assurance that a process or system will consistently produce their medicine to safe standards.

Validation expert Jeff Odum says, "validation typically costs between 5 and 9 per cent of the capital cost of a facility. For plant managers commissioning a 100 to 150 million dollar plant, the savings that the BioNetwork Validation Academy can produce are already a significant incentive to locating in North Carolina." BioNetwork Director Susan Seymour concurred, "even setting aside the millions of dollars of savings on a facility startup, the Validation Academy will create savings in ongoing operational costs and efficiencies."

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