James L. Vesper

Quality and GMP Auditing (eBook, ePUB)

Clear and Simple

• Format: ePub

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

---

Dieser Download kann aus rechtlichen Gründen nur mit Rechnungsadresse in A, B, BG, CY, CZ, D, DK, EW, E, FIN, F, GR, HR, H, IRL, I, LT, L, LR, M, NL, PL, P, R, S, SLO, SK ausgeliefert werden.

Produktdetails

• Verlag: Taylor & Francis eBooks
• Seitenzahl: 240
• Erscheinungstermin: 31. Juli 1997
• Englisch
• ISBN-13: 9781040204375
• Artikelnr.: 72538589

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.

---

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.