QUOTED. Jan. 19, 2018. Ricki Chase.
Executive SummaryCheck out what consultant (and former FDAer) Ricki Chase had to say about why it's important for device manufacturers to keep tabs on their suppliers of components and services.
"Suppliers can affect your [process] validation activities. Suppliers can completely destroy everything you've put a lot of hard work into. So, it's really, really important to know where your suppliers stand. And if you don't believe it's really, really important, just ask FDA – an investigator can tell you all about how it's really, really important when they're writing an observation on an FDA-483 because you failed to make sure your vendors were doing things the right way." –Ricki Chase, compliance practice director, Lachman Consultant Services
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