1. The “business” of investigations;Barsky;J. GXP Comp.,2008
2. CAPA and root cause analysis;Bartholomew;Pharma. Manu.,2006
3. FDA Risk-based Inspection Model;Campbell,2008
4. Eliminating defects in the vertical supply chain;Eckert;Qual. Dig.,2008
5. Guidance for Industry: Quality Systems Approach to Pharmaceutical cGMP Regulations, Rockville;FDA;MD: CDER/CBER,2006