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Pharmaceutical Pre-Approval Inspections A Guide to Regulatory Success 2e (HB) at Meripustak

Pharmaceutical Pre-Approval Inspections A Guide to Regulatory Success 2e (HB) by Hynes, Informa Healthcare

Books from same Author: Hynes

Books from same Publisher: Informa Healthcare

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  • General Information  
    Author(s)Hynes
    PublisherInforma Healthcare
    Edition2
    ISBN9780849391842
    Pages278
    BindingHard Back
    LanguageEnglish
    Publish YearJanuary 2008

    Description

    Informa Healthcare Pharmaceutical Pre-Approval Inspections A Guide to Regulatory Success 2e (HB) by 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 organizations gain rapid regulatory approval.


    Key Features:-

    • chronicles the major shifts in inspection activity as evidenced by a systems-based approach to inspe
    • demonstrates what each area of pharmaceutical development, from research and development to training
    • focuses on traditional development and submission activities, but also discusses cases where the tra