Approach: ISPE C&Q Baseline Guide 5 2nd Edition Highlights

Thursday, September 19, 2019
4:45 pm - 8:00 pm

The ISPE Commissioning and Qualification 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 CoP 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.

Areas of Focus:

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. The 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 C&Q guide, clearly understand of the updates within the revised Baseline Guide, understand the tools provided to projects to drive efficiency and to reduce duplication of C&Q efforts during execution.

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Speaker

Steven J. Wisniewski
Principal Compliance Consultant
Commissioning Agents, Inc.

Steven Wisniewski is Principal Consultant for CAI. Steve has more than 35 years’ experience in the pharmaceutical, biotech, and device industries. Steve 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.


Location

GLY Construction Inc.
200 112th Ave NE, Suite 300
Bellevue, WA 98004

$50 for all attendees - drinks and food provided!

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Sponsors

CAI
GLY