Quality and GMP Auditing

Quality and GMP Auditing: Clear and Simple

by VESPER, JAMES L.

Type Book
Rate 0.0 /5

"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 approac…

Read More ↓
Details
Files
Reviews
Download

Title Statements

  • Full title :Quality and GMP Auditing : Clear and Simple / James L. Vesper.

Summary

"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)!"--Provided by publisher.

Read More ↓

Edition Statements

  • Publication Date:1997.
  • Edition:First edition

Publication Statements

  • Publisher(s):CRC Press
  • Place of Publication:Boca Raton, FL
  • Language:eng
  • Publication Date:1997.

The Physical Object

  • Description:1 online resource : : text file, PDF

Edition Identifiers

  • ISBN:9781439805770, 1439805776
  • DOI:10.1201/9781439805770
  • oclc:on1027777786
  • LC Classification:RS192
  • Dewey Decimal:615.10685

Table of Contents

Chapter 1 What Is a GMP or Quality Audit? -- chapter 2 The Big Picture -- chapter 3 Regulatory Requirements and Expectations for GMP Audits -- chapter 4 Your Auditing Policy and SOP -- chapter 5 Types of Audits -- chapter 6 Audit Approaches -- chapter 7 Auditor Qualifications and Skills -- chapter 8 Phase I: Preparation -- chapter 9 Phase II: Conduct the Audit -- chapter 10 Interviewing Auditees -- chapter 11 Phase III: Analyzing Audit Data -- chapter 12 Phase IV: The Audit Report -- chapter 13 Phase V: Follow-up and Closure -- chapter 14 Auditing Vendors and Contractors -- chapter 15 Being Audited.

Read More ↓

Subjects

Industrie pharmaceutique -- Normes Pharmaceutical industry -- Standards

Writers

VESPER, JAMES L.

Rate & Review

0.0/5
(0 people Voted)

No reviews yet. Be the first to rate this work.

Files & Downloads

No downloadable files are registered for this work yet.

Log in to request a copy