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ISPE The Science and Risk Based Approach to C&Q: The Road to ASTM E2500

Mar 21, 2013


The introduction of ASTM E2500 and ICH Q9 (Quality Risk Management) have provided the Pharmaceutical Industry with a methodology to optimize commissioning and qualification activities resulting in improved compliance and a defined focus on product quality and patient safety.  Efficient implementation of these practices provides the additional opportunity to reduce capital project timelines, and reduce life cycle costs. 

Although the ASTM and ICH documents indicated the “What” in defining a science and risk based approach to system verification, the “How’s” of practical and efficient implementation of the supporting work processes had not been fully described and associated best practices had not been developed. 

In order to help fill this need, the C&Q CoP sponsored the development of the ISPE Guide: Science and Risk Based-Approach for the Delivery Facilities, Systems, and Equipment that presents a structured life cycle approach to the delivery and verification of GxP regulated facilities, systems, and equipment. It supports the ASTM industry and ICH regulatory initiatives, including science based risk management approaches, a focus on product and process understanding, and the application of Quality by Design concept. In addition the C&Q COP formed a Task Team to develop a Good Practice Guide - Applied Risk Management for C&Q that maps the transition and provides implementation strategies for moving from the traditional, or “Baseline Guide 5 approach” based on Impact Assessment to ICH Q9/ASTM quality risk management implementation. 

This presentation will provide an overview these recent ISPE guidance documents and provide an overview of the implementation principles and elements contained therein.


Dave Dolgin, Senior Quality Program Manager, Quality Systems Group, AbbVie
Dave Dolgin is currently a Senior Quality Program Manager in the Quality Systems group of AbbVie (formerly Abbott). Dave has more than 35 years of Quality Assurance and Validation experience in the pharmaceutical industry and has been with Abbott/AbbVie since 1991.  Dave led the C&Q task team in development of  ISPE’s Good Practice Guide - Applied Risk Management for C&Q.

Steve Wisniewski, Principal Compliance Consultant, Commissioning Agents, Inc.
Steven J. Wisniewski is Principal Compliance Consultant for Commissioning Agents, Inc. (CAI), 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.

Mr. Wisniewski offers 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 Drug and Device Associates. Mr. Wisniewski has served in 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. He served four terms as Chairman of the ISPE Community of Practice for Commissioning and Qualification, was a lead on the Task Team that drafted the recent ISPE Guide in support of Risk-based Qualification and served on the Task Team that completed the ISPE Good Practice Guide to address transitional Science and Risk-based (ICH Q9) approaches for C&Q. He was on the Team that developed the ASTM E2500 Standard and has also served as course leader and/or presenter at multiple ISPE C&Q conferences and co-authored several C&Q related articles.

Click Here for Handouts from Dave Dolgin

Click Here for Handouts from Steve Wisniewski



Registration & Networking Reception: 5:30 pm to 6:30 pm
Program: 6:30 pm to 8:30 pm


Before 03/14/2013:
Members $50
Non Members $95*
Student Members $5

After 03/14/2013:
Members $60
Non Members $115*
Student Members $10

*Join ISPE now and pay the Member rate. Join within one week of this meeting, and we'll refund you the difference between the Member and Non-Member rate! Contact the office at (781) 647-4773 or office@ispeboston.org for more information.

PLEASE NOTE: Attendees may only attend one program as a non-member.

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