Pharmaceutical Pre-Approval Inspections
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Published By CRC Press

9780429120985
Latest Documents Most Cited Documents Contributed Authors Related Sources Related Keywords

The Systems-Based Pre-Approval Inspection

2016 ◽  
pp. 95-105
Author(s):  
Elizabeth M. Troll

Training Requirements in Product Development: A Key to a Successful Pre-Approval Inspection

2016 ◽  
pp. 83-94
Author(s):  
Tammy Chaney Cullen ◽  
Marie Crabb-Donat
Keyword(s):  
Product Development ◽  
Training Requirements

Conducting Stability Studies During Development to Ensure Successful Regulatory Approval

2016 ◽  
pp. 207-224
Author(s):  
Julianne Eggert ◽  
Carol Fowler
Keyword(s):  
Regulatory Approval ◽  
Stability Studies

Critical Role of the Pharmaceutical Scientist in Product Development and Preparing for Pre-Approval Inspections

2016 ◽  
pp. 59-81
Author(s):  
Mahdi Fawzi ◽  
Richard Saunders ◽  
Parimal Desai
Keyword(s):  
Product Development ◽  
Critical Role ◽  
Pharmaceutical Scientist

All Dressed Up but No Approval to Go: The Consequence of Failing an FDA Pre-Approval Inspection

2016 ◽  
pp. 261-264
Author(s):  
Alan Minsk ◽  
David Hoffman

Concepts in Quality by Design for Drug Development and Manufacture

2016 ◽  
pp. 149-190
Author(s):  
Ken Morris ◽  
Ryan McCann
Keyword(s):  
Drug Development ◽  
Quality By Design

Integral for Successful PAI: The Quality Assessment Program

2016 ◽  
pp. 243-259
Author(s):  
Graham Bunn
Keyword(s):  
Quality Assessment ◽  
Assessment Program
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