Wednesday, May 20, 2009

Speakers
Brian McCole, Director CAPA and Quality Systems, Life Sciences
Michael Ambrose, AVP Compliance and Quality Systems, Patni Life Sciences

Webinar Highlights
In today’s competitive Life Sciences industry, Quality Systems can no longer merely function as just a compliance tool; they must operate as an integral and strategic component of the business, which drives operational efficiency towards continuous improvements. By closing the loop between their Control (e.g. Facilities, Design Laboratory/Testing, Product, Customer, etc) and CAPA functions – companies can gain that strategic advantage through directly-trigged quality activities, a robust CAPA process, and instantaneous visibility into their Quality System information via dashboards.

During this one hour Webinar, we will discuss steps to achieve a closed-loop Quality System, including:

• A review of recent FDA Warning Letters and the regulatory requirements surrounding the Quality System Model
• Introduction of the Quality System Maturity Model leading into a closed-loop Quality System
• Patni’s approach to a closed-loop Quality System through our iCAPA Solution framework for both SAP and non-SAP environments

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