James L. Vesper

Quality and GMP Auditing (eBook, PDF)

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• Format: PDF

Produktbeschreibung

More than just a checklist of audit questions, this guidebook contains proven methods and techniques for performing effective audits. Completely covering the four key competencies essential for successful GMP audits, the book explores the rationale behind using audits as a quality tool and explains 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 help readers prepare checklists and standards so audits become more effective, consistent, and standardized.

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Produktdetails

• Verlag: Taylor & Francis
• Seitenzahl: 240
• Erscheinungstermin: 31. Juli 1997
• Englisch
• ISBN-13: 9781439805770
• Artikelnr.: 57903153

Autorenporträt

Vesper, James L.

Inhaltsangabe

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. Phase I: Preparation.
Phase II: Conduct the Audit. Interviewing Auditees. Phase III: Analyzing
the Audit Data. Phase IV: The Audit Report. Phase V: Follow-up & Closure.
Auditing Vendors & Contractors. Being Audited.

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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. Phase I: Preparation. Phase II: Conduct the Audit. Interviewing Auditees. Phase III: Analyzing the Audit Data. Phase IV: The Audit Report. Phase V: Follow-up & Closure. Auditing Vendors & Contractors. Being Audited.