Pharmaceutical, Medical Device, and BioTech companies are required to detect and react to non-conformances and ensure that appropriate actions are taken to correct and prevent future occurrences. Still, more than half of the FDA Form 483 observations and warning letters cite Corrective Action / Preventive Action (CAPA) incident management deficiencies.
Every Life Sciences company needs to have an effective CAPA system in place to minimize risk and ensure compliance with regulations, but maintaining...(read more)
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