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9781574910551

Quality and GMP Auditing: Clear and Simple

by Vesper; James L.
  • ISBN13:

    9781574910551

  • ISBN10:

    1574910558

  • eBook ISBN(s):

    9781040204375

  • Format: Hardcover
  • Copyright: 1997-07-31
  • Publisher: CRC Press

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Summary

This guidebook provides proven methods and techniques for performing effective audits that serve your department, your company, and you. Topics covered relate to the four key competencies essential for successful GMP audits. Includes the rationale for auditing as an important quality tool, along with the audit cycle, broken into five distinct phases. To focus the power of auditing on a particular situation, several different types of audits are presented, as are more than a dozen audit approaches with general questions to answer and specific items to examine. These tools will help you prepare checklists and standards so audits become more effective, consistent, and standardized. The book includes profiles of seasoned professionals in drug and device auditing, who share their experiences (the good and the bad)!

Table of Contents

Chapters cover:
o What Is a GMP or Quality Audit?
o Big Picture
o Regulatory Requirements & Expectations for GMP Audits
o Your Auditing Policy & SOP
o Types of Audits
o Audit Approaches
o Auditor Qualifications & Skills
o Phase I: Preparation
o Phase II: Conduct the Audit
o Interviewing Auditees
o Phase III: Analyzing the Audit Data
o Phase IV: The Audit Report
o Phase V: Follow-up & Closure
o Auditing Vendors & Contractors
o Being Audited

Supplemental Materials

What is included with this book?

The New copy of this book will include any supplemental materials advertised. Please check the title of the book to determine if it should include any access cards, study guides, lab manuals, CDs, etc.

The Used, Rental and eBook copies of this book are not guaranteed to include any supplemental materials. Typically, only the book itself is included. This is true even if the title states it includes any access cards, study guides, lab manuals, CDs, etc.

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