1. The evolution of the food and drug administration : pre-new drug application approval inspection / Martin D. Hynes III and Jeanette M. Buckwalter -- 2. FDA's risk-based approach to inspections / Ronald F. Tetzlaff and Jeanette M. Buckwalter -- 3. Critical role of the pharmaceutical scientist in product development and preparing for pre-approval inspections / Mahdi Fawzi, Richard Saunders, and Parimal Desai -- 4. Training requirements in product development : a key to a successful pre-approval inspection / Tammy Chaney Cullen and Marie Crabb-Donat -- 5. The systems-based pre-approval inspection / Elizabeth M. Troll -- 6. A cGMP risk assessment and management strategy : guidelines for the pre-approval inspection / Carmen Medina -- 7. Concepts in quality by design for drug development and manufacture / Ken Morris and Ryan McCann -- 8. Equipment cleaning during pharmaceutical product development and its importance to pre-approval inspection / Lisa Ray -- 9. Conducting stability studies during development to ensure successful regulatory approval / Julianne Eggert and Carol Fowler -- 10. Computer systems validation during the drug development process in anticipation of pre-approval inspections / Ludwig Huber -- 11. Integral for successful PAI : the quality assessment program / Graham Bunn -- 12. All dressed up but no approval to go : the consequence of failing an FDA pre-approval inspection / Alan Minsk and David Hoffman.