Steven Wisniewski

Self Employed
Retired Principal Consultant
Steven Wisniewski has over 40 years’ 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 in 1991. Wisniewski served four years as founding chair of the ISPE Community of Practice for C&Q and was on the ASTM task team that developed the ASTM E2500 Standard and on a team that just completed updating the Standard. He has served multiple Task Teams focusing on QRM C&Q Guidance and developed the ISPE QRM C&Q Training Course. 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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Features
ASTM E2500-25 Standard Guide: Approval and Updates

ASTM E2500, issued in 2007, has been the primary standard guide defining what is required to apply quality risk management (QRM) to achieve the qualification of facilities, systems, and equipment in support of validation and process validation. A major update was undertaken in 2024 to better align the guide with current regulatory and industry guidance and current best practice.