CAPA and FDA: Responding to Requests

Pharmaceutical Technology spoke with Regulatory Compliance Associates about developing a corrective action and preventive action (CAPA) plan.   PharmTech: What are the best practices for developing a detailed CAPA?   RCA: A CAPA program requires a well-documented system that determines the root cause of non-conformances, system failures, or process problems, corrects them, and prevents them from … Continue reading CAPA and FDA: Responding to Requests