Steven J. Wisniewski is Principal Compliance Consultant for Commissioning Agents, Inc. a highly respected provider of technical services for biotech and pharmaceutical manufacturers world-wide. Commissioning Agents focuses on the manufacturing process, with services including commissioning, validation, technology transfer, PAT, maintenance programs, SOPs, training and cGMP compliance. Wisniewski has more than 30 years experience in the pharmaceutical, biotech, and device industries. Prior to joining CAI he was Senior Associate and Director of Compliance for IPS. Steve was senior consultant for Drug and Device Associates and has served in manufacturing facility and corporate 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 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, and was chairman of the board in 1991. Wisniewski served four years as chairman of the ISPE Community of Practice for Commissioning and Qualification, and was on the ISPE task team that developed the ASTM E2500 Verification Standard. In addition he served as a leader of the Task Team that drafted the ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment, and served on the Task team that developed the ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification.