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Image of - Pharmaceutical Pre-Approval Inspections A Guide to Regulatory Success | 2nd Edition | Hardcover
Pharmaceutical Pre-Approval Inspections A Guide to Regulatory Success | 2nd Edition | Hardcover

Pharmaceutical Pre-Approval Inspections A Guide to Regulatory Success | 2nd Edition | Hardcover

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. 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

Highlights

  • binding-icon

    9780849391842

    ISBN:

  • binding-icon

    Hynes

    Author:

  • binding-icon

    304

    Pages:

  • binding-icon

    239 gm

    Weight:

  • langauage-icon

    English

    Language:

  • date-icon

    2008

    Year:

  • edition-icon

    2nd Edition

    Edition:

  • binding-icon

    Hardcover

    Binding:

₹2396

₹2995

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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