Description: Corrective Actions/Preventive Actions are an integral part of a robust quality system in both pharmaceutical and medical device manufacturing. The ability to be able to determine the root cause of a product or manufacturing issue and put effective corrections in place is critical to continued product quality. Understanding the process of root cause investigations and the appropriate corrective actions/preventive actions will help ensure continued product quality. CAPA is a required part of both pharma and medical device quality systems. An understanding of the CAPA system and putting into place a robust process will help ensure quality products and smooth manufacturing. |