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Preparing for FDA Pre-Approval Inspections : A Guide to Regulatory Success, Second Edition

By: Martin D. Hynes (Edited by)

Out of stock

Ksh 45,600.00

Format: Hardback or Cased Book

ISBN-10: 0849391849

ISBN-13: 9780849391842

Edition Number: 2

Publisher: Taylor & Francis Inc

Imprint: CRC Press Inc

Country of Manufacture: GB

Country of Publication: GB

Publication Date: Mar 5th, 2008

Publication Status: Active

Product extent: 304 Pages

Weight: 544.00 grams

Product Classification / Subject(s): Pharmaceutical technology

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Preparing for FDA Pre-Approval Inspections

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

Get Preparing for FDA Pre-Approval Inspections by at the best price and quality guranteed only at Werezi Africa largest book ecommerce store. The book was published by Taylor & Francis Inc and it has pages. Enjoy Shopping Best Offers & Deals on books Online from Werezi - Receive at your doorstep - Fast Delivery - Secure mode of Payment

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