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The Criticality of Process Validation

By: Todd Owens and Raghu Vadlamudi

Released By Donatelle, A DuPont Business

Process validation is a critical part of medical device manufacturing, but it often doesn’t get the attention it requires. This article explains why validation is imperative in medical device manufacturing, illuminates some regulatory changes currently underway, outlines the steps of creating validation processes, and identifies the personnel who should create and maintain them. Further, it discusses what medical device companies should be looking for in a contracted manufacturer regarding validation processes.

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