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Course Description:

Implementing an effective system for corrective action and preventive action can be a major challenge. FDA illustrates the point in its published information on Warning Letters. FDA cited the CAPA subsystem in 81 of 89, 91%, of Warning Letters issued in 2010, the most recently available data. The CAPA subsystem includes nonconforming material, corrective and preventive action, and complaints (820.90, 820.100, 820.198). The trend continues in recent warning letters.