1st Edition

Quality and GMP Auditing Clear and Simple

By James L. Vesper Copyright 1997
240 Pages
by CRC Press

240 Pages
by CRC Press

240 Pages
by CRC Press

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... Read more
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.

Biography

James L. Vesper