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Quality and GMP Auditing : Clear and Simple - James L. Vesper

Quality and GMP Auditing

Clear and Simple

Hardcover Published: 31st July 1997
ISBN: 9781574910551
Number Of Pages: 240

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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)!

What Is a GMP or Quality Audit?
Big Picture
Regulatory Requirements & Expectations for GMP Audits
Your Auditing Policy & SOP
Types of Audits
Audit Approaches
Auditor Qualifications & Skills
Conduct the Audit
Interviewing Auditees
Analyzing the Audit Data
The Audit Report
Follow-up & Closure
Auditing Vendors & Contractors
Being Audited
Table of Contents provided by Publisher. All Rights Reserved.

ISBN: 9781574910551
ISBN-10: 1574910558
Audience: Professional
Format: Hardcover
Language: English
Number Of Pages: 240
Published: 31st July 1997
Publisher: CRC PR INC
Country of Publication: US
Dimensions (cm): 23.5 x 15.24  x 1.91
Weight (kg): 0.47
Edition Number: 1