This Second Edition is an essential guide to preparing for FDA pre-approval inspections-taking into account current trends in FDA expectations and inspection activities, such as the GMPs of the 21st Century, quality systems-based approach to inspections, risk-based inspections, quality by design, process analytical technology, design space, etc. Th

chapter 1|26 pages

The Evolution of the Food and Drug Administration: Pre-New Drug Application Approval Inspection

ByMartin D. Hynes, Jeanette M. Buckwalter

chapter 2|32 pages

FDA’s Risk-Based Approach to Inspections

ByRonald F. Tetzlaff, Jeanette M. Buckwalter

chapter 3|23 pages

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

ByMahdi Fawzi, Richard Saunders, Parimal Desai

chapter 4|12 pages

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

ByTammy Chaney Cullen, Marie Crabb-Donat

chapter 5|11 pages

The Systems-Based Pre-Approval Inspection

ByElizabeth M. Troll

chapter 7|42 pages

Concepts in Quality by Design for Drug Development and Manufacture

ByKen Morris, Ryan McCann

chapter 9|18 pages

Conducting Stability Studies During Development to Ensure Successful Regulatory Approval

ByJulianne Eggert, Carol Fowler

chapter 11|17 pages

Integral for Successful PAI: The Quality Assessment Program

ByGraham Bunn