Quality and GMP Auditing

Clear and Simple

James L. Vesper (Autor)

Buch | Softcover

240 Seiten

2019
CRC Press (Verlag)
978-0-367-40090-3 (ISBN)

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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)!

Vesper, James L.

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.

Erscheinungsdatum	30.09.2019
Verlagsort	London
Sprache	englisch
Maße	152 x 229 mm
Gewicht	453 g
Themenwelt	Naturwissenschaften ► Biologie
Themenwelt	Technik
ISBN-10	0-367-40090-1 / 0367400901
ISBN-13	978-0-367-40090-3 / 9780367400903
Zustand	Neuware