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Preparing for FDA Pre-Approval Inspections

Preparing for FDA Pre-Approval Inspections

Martin D. Hynes

123,04 €
IVA incluido
Disponible
Editorial:
Taylor & Francis Ltd
Año de edición:
2019
Materia
Química
ISBN:
9780367452711
123,04 €
IVA incluido
Disponible

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Sobre IBD

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.

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