LIBROS DEL AUTOR: martin d hynes

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  • Preparing for FDA Pre-Approval Inspections
    Martin D. Hynes
    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...
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    117,62 €