For companies to improve their performance, they have to understand their failures. But deep understanding requires more than just making a bit more effort – it needs a change of mindset where ...

Performing corrective action and preventive action (CAPA) activities is often necessary to investigate a manufacturing deviation and prevent it from reoccurring. Pharmaceutical Technology asked Joe ...

A risk assessment should be performed as part of the CAPA process, says Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates. A: This is an interesting question because it ...