CQV: New Guidance and Advanced Approaches

When: November 14, 2019, 5:30 pm - 8:30 pm
Where: Takeda, 200 Shire Way, Lexington, MA

This discussion panel seeks to explore the approaches and implementations of a risk based C&Q program for various types of pharmaceutical facilities.

In a rapidly evolving industry where new technologies, shorter time-to-market, and multiproduct facilities are prevalent, organizations must transition to a science and risk-based approach to commissioning and qualification in order to maintain a compliant and efficient program. This combination of presentations and a discussion panel seeks to explore the approaches and implementations of a risk based C&Q program for various types of pharmaceutical facilities to demonstrate they are fit for their intended purpose. The panelists will discuss the tactics their own organizations have taken in adopting integrated, compliant, science and risk based approaches towards qualification of systems, utilities, and equipment. A Q&A portion will follow the initial presentations and allow for the audience to pose questions to experts about current industry best practices for commissioning and qualification. With the recent release of the ISPE Baseline Guide: Commissioning and Qualification Second Edition, this panel event aims to highlight the latest practices in the new Guide. The newest ways to implement a science and risk-based approach in a changing landscape will be identified.

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