Home » Devicemakers Need to Trend Rare Unexpected Events
Devicemakers Need to Trend Rare Unexpected Events
Devicemakers should not risk warning letters or Form 483s by using the low frequency of a nonconformance as a reason not to track the event. If the
average frequency for a nonconformance is extremely low, even one occurrence could be a trend, James Miller, senior quality analyst for core quality systems
at Roche Diagnostics, said during an FDAnews webinar.
Devices & Diagnostics Letter
Devices & Diagnostics Letter
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