James L. Vesper

Quality and GMP Auditing (eBook, PDF)

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• Format: PDF

Produktbeschreibung

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 phase

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Produktdetails

• Verlag: Taylor & Francis eBooks
• 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.