FDA 483s Related to CAPA Issues - Did You Know?


Did You Know?

Did you also know that your CAPA system relies almost entirely--at least initially--on the effective management of events such as nonconformances and deviations?

It's also interesting to note that sophisticated CAPA training trends are taking quality managers away from a reliance on "CAPA expertise" and helping them to focus on "common sense" and logical inferences. This new "CAPA concept" could literally become the revolutionary quality center of many blood and biologics businesses and organizations. For many biologics companies, the trend may be especially beneficial as they have some of the most expensive pipelines that exist in the life science industries. More effective event management and CAPA automation could mean the savings of thousands, perhaps even hundreds of thousands, of dollars.


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