ISPE Baseline Guide Vol 5: Commissioning & Qualification 2nd Edition Highlights
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.
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.
Speaker:
Chip Bennett, PMP, Assistant Director, Global C&Q, CAI
Reception:
Food and beverages following the presentation.
Parking:
Please park in the visitor spots located left and right of the MedImmune main lobby entrance, and walk in at the main lobby. ISPE guests will be escorted to the meeting. Please make sure to bring your ID.