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Powerful Closed-loop CAPA - Meeting FDA Expectations

Event Details

Powerful Closed-loop CAPA - Meeting FDA Expectations

Time: August 7, 2012 from 10am to 11:30am
Location: Online Event
Street: 2600 E. Bayshore Road
City/Town: Palo Alto
Website or Map: http://www.complianceonline.c…
Phone: +1-650-620-3915
Event Type: medical, training
Organized By: Referral
Latest Activity: Jun 25, 2012

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Event Description

This 90-minute webinar will show how you can implement a closed-loop CAPA system that meets CGMP requirements and U.S. FDA expectations. You will learn simple, but powerful, tools and methods that you can use regularly and systematically to define and resolve root causes, not just symptoms.

Why Should You Attend:

The most important area audited by the FDA is CAPA - it assures the FDA that company is in compliance without the Agency constantly auditing it.

Closed-loop CAPA mandates a repeatable, systematic Failure Investigation and Root Cause Analysis - define, locate and resolve the basic problem(s) or root cause(s). A full-capture investigation, verification/validation, monitoring, change control methodology, coupled with accurate root cause analysis is crucial to a "closed-loop" CAPA system, that meets / exceeds CGMP requirements and U.S. FDA expectations.


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