Cover image for Pharmaceutical pre-approval inspections a guide to regulatory success
Title:
Pharmaceutical pre-approval inspections a guide to regulatory success
Author:
Hynes, Martin D.
ISBN:
9781420020489
Edition:
2nd ed.
Publication Information:
New York : informa healthcare, 2008.
Physical Description:
x, 278 p. : ill.
Series:
Drugs and the pharmaceutical sciences ; v. 181
Series Title:
Drugs and the pharmaceutical sciences ; v. 181
Contents:
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.
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