CAPA – Corrective & Preventive Action Requirements and Medical Device Industry Practice

Corrective and Preventive Action (CAPA) Requirements Training

Course Duration: 2 Days

This two-day seminar covers all phases of initiating CAPA from non-conformances through implementation and effectiveness verification of the corrective actions. The Standards from which this training has been derived are ISO 13485 and 21 CFR 820, as well as other world-recognized standards.

Risk Management is addressed as integral to the CAPA processes and must be integrated into the selection of appropriate mitigation or corrective processes. All will be in accordance to ISO 14971.

The concept of Preventive Action will be discussed, and correctly interpreted to be an independent process, which may not be required or tied to each Corrective Action