Compliance Advice: Preventive Action: CAPA’s Stepsister

Posted 01 January 2009 | By Gale E. Van Buskirk Molly C. Andresen 

Past articles concerning corrective and preventive action (CAPA) have focused on corrective action but have not mentioned preventive action. How do they differ? Please provide some examples because our Notified Body wants us to initiate a preventive action program. During our last inspection, the FDA investigator never asked about our preventive action program.

Regulatory Focus newsletters

All the biggest regulatory news and happenings.