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Jul 2013
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Venue TBD Washington , District of Columbia
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Sustaining Effective CAPA Systems

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Overview

Successfully implementing and documenting corrective and preventive actions (CAPAs) is one of the critical processes in a medical device and pharmaceutical manufacturing company’s day-to-day quality operations. CAPAs carry significant implications for both product quality and compliance with FDA regulatory directives, and remain vital to any company’s ability to address incidents that inevitably arise in the manufacturing processes. Due to this, it is critical to take necessary steps to prevent them from re-occurring.

Attending the marcus evans Sustaining Effective CAPA Systems Conference will enable attendees  to ensure a systematic and measurable CAPA program that can correct problems at all levels of the organization. Furthermore, the conference will address requirements mandated not only by the FDA but other regulatory bodies to effectively investigate and locate causes and correct them. It will also expand on establishing an effective CAPA system through discussing challenges such as identifying non-conformances, root cause analysis, assess and prioritize non-conformance based on risk, implement proper corrective and preventive action that will ensure their CAPA system is robust.

Attending this conference will allow you to:

-          Comprehend the FDA’s expectations and their assessment criteria for CAPA systems

-          Navigate the different global regulatory requirements for corrective actions

-          Develop procedures for assessing and prioritizing non-conformance based on risk

-          Verify the effectiveness of corrective and preventive actions

-          Explore different methodologies when identifying true root causes

Testimonials:

“This was a very nice blend of medical device companies with good speakers that provided interesting observations of the varying use of continuous improvement methods. I genuinely learned something new from nearly all of the presentations.” – Baxter Healthcare Corp.

“An excellent forum to understand industry challenges.” – Boston Scientific

“Great conference; I am glad I attended.” – Ventana Medical Systems Inc.

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