Course offering number:0812-205
Course ID:
1954
Commissioning, Qualification and Validation
8-10 December 2008
Amsterdam, The Netherlands
Steven 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 then 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.
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