Building a Defensible CAPA Governance Model for FDA Audits in 2023 Building a Defensible CAPA Governance Model for FDA Audits in 2023 As regulatory landscapes evolve, organizations in the pharmaceutical sector must remain nimble in their approach to compliance and quality management. Particularly within the scope of Corrective and Preventive Actions (CAPA), establishing a robust governance model is essential to withstand the scrutiny of regulatory audits. This comprehensive tutorial will guide you through the critical steps to develop a defensible CAPA governance model that meets FDA audit requirements in 2023. We will harmonize the understanding of CAPA systems and their…