Steven Wisniewski

CAI Retired
Principal Consultant
Steven Wisniewski has more than 40 years of experience in the pharmaceutical and biotech industries. He recently retired as Principal Consultant for CIA. Prior to CAI he was Senior Associate and Director of Compliance at two pharma consulting organizations. He has served in manufacturing facility and corporate senior management roles at Sterling Drug and Bausch & Lomb. He has completed a wide variety of pharmaceutical manufacturing and related projects. He holds a BSME from Rensselaer Polytechnic Institute. Participated in a PDA Technical Report draft team for application of QRM to Facilities, systems, and equipment. Served on the ISPE board of directors beginning in 1982 and was chairman of the board in 1991. Wisniewski served four years as founding chair of the ISPE Community of Practice for Commissioning and Qualification and was on the ASTM task team that developed the ASTM E2500 Standard and currently on a Task Team updating the Standard. He has served multiple Task Teams focusing on QRM C&Q Guidance. He was a member of the leadership for a Task Team that produced the 2nd Edition of Baseline Guide 5 for C&Q and the 2nd Edition, Good Engineering Practice, Good Practice Guide.

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