Quick Tip: The way to success in FDA inspections is through quality culture
Insight from a conversation with Vincent Cafiso
Listen to the full podcast here
LTR 34: Build a culture of Quality to achieve inspection-readiness at all times
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The news of an FDA investigator showing up unannounced at a medical device manufacturing facility generally sends a wave of panic throughout the organization! Even when it is a planned inspection, or an audit visit from a notified body, there is a high level of stress before, during and after the inspection. A lot of effort is spent in “getting ready” f…