Pharmaceutical Technology spoke with Sharon Ayd, executive vice-president of Pre-approval Pharmaceuticals and chief scientific officer at Regulatory Compliance Associates, about developing a corrective action and preventive action (CAPA) plan.   PharmTech: What are the best practices for developing a detailed CAPA?   Ayd: A CAPA program requires a well-documented system that determines the root cause of … Continue reading Responding to FDA CAPA Requests