2018 - Powerful Closed-loop CAPA - Meeting FDA Expectations

U.S. FDA's CAPA Expectations
What is Closed-loop CAPA?
Correction, Corrective Action, Preventive Action
Failure Investigation Using an FI Template
7 Powerful Tools for Root Cause Analysis
Investigation Detail - Root or Probable Cause
Impact - Often Neglected but of Major Importance
Effectiveness - Determining and Monitoring
Institutionalize vs. Entropy