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Baseline Guide 12 Overview - Science and Risk Based Approach
Baseline Guide 12 Overview - Science and Risk Based Approach
Baseline Guide 12 Overview - Science and Risk Based Approach for the Delivery of Facility Systems & Equipment
This presentation provides an overview and introduction to the completed draft of new ISPE Baseline® Guide 12: Science and Risk Based Approach for the Delivery of Facilities, Systems, and Equipment. The Guide provides the "how to" for implementation of the verification approach described in the ASTM E2500-07 Standard. At the conclusion of this session, participants will be able to:
  • Understand risk-based C&Q approaches
  • Understand challenges and get new ideas for implementing risk-based methodologies

  • Speaker Biography
    Steven Wisniewski is Principal Consultant for CAI Consulting, a highly respected provider of consulting and technical services for biotech and pharmaceutical manufacturers worldwide. CAI Consulting focuses on the manufacturing lifecycle process, with services including commissioning, validation, technology transfer, owner Project Management, maintenance programs, SOPs, training and cGMP compliance. Wisniewski has more than 35 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 Drug 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 produced the ISPE Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems, and Equipment, and was a leader the Task team that developed the ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification.
    Discounted member price: 49.00
    Your price: 149.00
    You could save 67.1%
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    This self-paced, pre-recorded course includes a downloadable presentation for note-taking, engaging graphics, links to regulatory information, assessments to measure your comprehension and the ability to start and stop at any time, beginning where you left off.

    ISPE CEUs are provided once you achieve an 80% passing grade and complete the evaluation as required.

    Approximate Course Duration: 60 minutes (this is a self-paced course)

    *NOTE* You will have 5 calendar days to access and complete this course from time of purchase.

    ISPE CEUs: .10 ISPE CEUs will be awarded upon successful completion of grading requirements

    Member Price: $ 49.00 / € 45.00
    Non Member Price: $ 149.00 / € 136.00
    Item #: WEBBG12US


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