9780470593752

Systems Engineering in the Pharmaceutical Industry: Solutions to Compliance Challenges

  • ISBN 13:

    9780470593752

  • ISBN 10:

    047059375X

  • Edition: 1st
  • Format: Hardcover
  • Copyright: 05/01/2017
  • Publisher: WILEY JOHN & SONS INC

Note: Not guaranteed to come with supplemental materials (access cards, study guides, lab manuals, CDs, etc.)

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Summary

This book addresses pharmaceutical quality and compliance in depth, focused on the impact of non-compliance with drug regulations in a practical way that helps pharmaceutical companies improve regulatory compliance by developing integrated quality systems. It features interviews from pharma industry executives from around the world who discuss their insight and experience with non-compliance issues. These issues are difficult to deal with and the author provides valuable guidance on why they occur and how to prevent them, based on real-life experience along with FDA data.

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