Implementing ASTM Standard for Verification Commissioning and Qualification

Applying the principles of ICH Q9 (Quality Risk Management) and ASTM E 2500-07 ensures GMP facilities and equipment are: "fit for use," perform satisfactorily, and may be used in the manufacturing, processing, packaging, and holding of a drug. This webinar reviews this approach and identifies critical aspects of manufacturing systems that will provide the focus for qualification/verification activities and allow for Good Engineering/Commissioning Practices to apply throughout the project lifecycle. At the conclusion of this session, participants will be able to:

  • Relate the ASTM Standard to GMP regulations and guidance documents
  • Explain the regulatory foundation for the risk-based approach
  • Understand the ISPE Baseline® Guide: Commissioning and Qualification Volume 5 and how it links to new concepts in the upcoming Baseline Guide: Science and Risk-Based approach for the Delivery of Facilities, Systems, and Equipment
  • Differentiate qualification versus verification
  • Differentiate between the new risk assessment approach versus the old one
  • Understand how the new draft USFDA Process Validation Draft links to ASTM E 2500
  • Understand the details on verification process flow
  • Implement verification through the C&Q process (FAT, SAT, IV, FV, PT)
  • Understand ways GEP can be used as a foundation for verification
Steven J. Wisniewski
Principal Compliance Consultant

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 an active Member of PDA and has participated on a Technical Report draft team, 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. Most recently he is a member of the leadership for a Task Team developing the second edition of Baseline Guide 5 for C&Q to incorporate QRM approaches.

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