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Course offering number:0901-401

Course ID:
1808
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IQ, OQ, PQ
January 21-22, 2009
Boca Raton, FL

Steven J. Wisniewski; Senior Associate and Director of Compliance, Integrated Project Services (IPS)

Steven J. Wisniewski is a Senior Associate and Director of Compliance for Integrated Project Services (IPS), a full serviceengineering firm specializing in the delivery of technical complex projects, which offers complete design/build, commissioning, validation and FDA compliance services for the pharmaceutical, biotech, health care and specialty manufacturing industries.

He offers more than 30 years experience in the pharmaceutical, biotech, and device industries. Prior to joining IPS, Mr. Wisniewski was Senior Consultant for Drug and Device Associates and has served in senior management roles at Sterling Winthrop and Bausch & Lomb. He has completed a wide variety of pharmaceutical manufacturing, filling and critical support operations to major R&D laboratories, facilities and upgrades. He served as a member of the ASTM Task Team that developed the International Consensus Standard for Verification (C&Q). Mr. Wisniewski holds a BSME from Rensselaer Polytechnic Institute, is a member of PDA and an active member of ISPE. He served on the ISPE Board of Directors beginning in 1982, served as Chairman of the Board in 1991 and currently serves as Chairman of the ISPE Community of Practice for Commissioning and Qualification and also serves on a Task Team in the process of revising the ISPE Baseline Guide for C&Q.