Webinar: Polishing an Old Gem: Commissioning & Qualification Baseline Guide Update

This webinar took place on 21 August 2019.  If you registered for the webinar, you received a link to the recording and the PPT slide deck 24 hours after the conclusion of the webinar.  Access will be available to those who registered for the webinar for 30 days following the webinar.  After 30 days, the recording will be placed here and Members of ISPE will have access to the webinar recording and PPT slide deck.  

If you have any questions, reach out to ISPE Member Services at ask@ispe.org.

This webinar will introduce the revision to the ISPE Baseline Guide Vol 5: Commissioning and Qualification. The guide was first issued in 2001 and reflective of that time. With emerging markets, changes in the regulatory landscape, advances in commissioning and qualification methodology, the commissioning and qualification Communities of Practice has rewritten the guide to align with present day requirements and best practices applicable to the current market. This guide considered applicable regulatory requirements as identified in ICH and ASTM E2500. The Guide provides a well-defined framework for a lifecycle QRM and risk-based approach to verification and documentation of fitness for use.

Overview Areas of Focus:

  • Rational for update of the revised guide
  • Structure of the Baseline Guide Vol 5: Commissioning & Qualification 2nd Edition
  • Review of the new elements including an integrated approach for developing and executing a commissioning and qualification plan, risk assessments and verification
  • Description of the new and improved methodologies to test once through verification and use & acceptance reports
  • Expanded role of Engineering using GEPs and Quality’s focus on that which is deemed critical

In this presentation, participants will be able to gain an overview of the new Baseline Guide Vol 5: Commissioning & Qualification 2nd Edition, clearly understand of the updates within the revised guide, understand the tools provided to projects to drive efficiency and to reduce duplication of commissioning and qualification efforts during execution.

Baseline Guide Vol 5: Commissioning & Qualification 2nd Edition

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Meet the Speaker:

Steven J. Wisniewski
Principal Compliance Consultant

Steven is Principal Consultant for CAI Consulting and 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, Senior Consultant for Drug and Device Associates and has served in manufacturing facility and corporate senior management roles at Sterling Drug and Bausch & Lomb. 

Steve served for 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. Most recently, Steve was the co-lead for developing the Baseline Guide Vol 5: Commissioning & Qualification 2nd Edition to incorporate QRM approaches.

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