C4A – CAPA, Failure Investigation and Root Cause Analysis to Meet FDA Expectations

November 1, 2019 @ 10:00 am – 11:30 am


By Angela Bazigos


We are often quick to ascribe fault to people rather than our systems, facilities, and operations. However, in this class, we will learn how to tell if you are too quick to ascribe guilt to people rather than probe deeper.

We will focus on improved techniques to get to the real cause of the problem. With this information you will be able to develop meaningful CAPAs that have a chance to remedy these problems, the first time.

We will focus on how to assess the success of these CAPA’s. This will lead to a significant reduction of repeat observations which will lead to improved efficiency and right first time operations. This live interactive presentation will also discuss the regulations associated with the detection, correction and prevention of human errors in GMP manufacturing and laboratory processes.

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