ARTICLES BY JOANNA GALLANT
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Do You Make This Critical Root Cause Analysis (RCA) Mistake?11/14/2016
In FDA-regulated industries, root cause analysis (RCA) is perhaps the most frequently used tool for identifying the source of a good manufacturing practice (GMP) deviation and determining an appropriate corrective and preventive action (CAPA). Yet, inadequate RCA is also one of the most common citations found in observations issued by FDA and other international regulatory bodies.
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Applying Human Performance Models In FDA-Regulated Environments4/15/2016
This article will provide regulatory context, address confidentiality concerns, and walk through an application based on an actual FDA 483.
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