Hynes, M: Preparing for FDA Pre-Approval Inspections A Guide to Regulatory Success, Second Edition
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- Hardcover ausgewählt
- Taschenbuch
- eBook
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Sprache:Englisch
Fr. 303.00
inkl. gesetzl. MwSt.,
Beschreibung
Produktdetails
Einband
Gebundene Ausgabe
Erscheinungsdatum
05.03.2008
Abbildungen
schwarz-weiss Illustrationen, Raster, schwarz-weiss, Tabellen, schwarz-weiss
Herausgeber
Martin D. HynesVerlag
Taylor and FrancisSeitenzahl
304
Maße (L/B/H)
22.9/15.2/2 cm
Gewicht
544 g
Sprache
Englisch
ISBN
978-0-8493-9184-2
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. The goal of this book is to help organizations gain rapid regulatory approval. Pharmaceutical Pre-Approval Inspections: A Guide to Regulatory Success, Second Edition:
- chronicles the major shifts in inspection activity as evidenced by a systems-based approach to inspections
- demonstrates what each area of pharmaceutical development, from research and development to training, is expected to provide to inspectors
- focuses on traditional development and submission activities, but also discusses cases where the transfer is from a domestic site to an international facility
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