Skip to main content

Quality

  • 2nd Edition, Volume 2 - April 1, 2022
  • Latest edition
  • Author: Kathleen E. McCormick
  • Language: English

Early spring sale

Nurture your knowledge

Grow your expertise with up to 25% off trusted resources.

Key features

  • Fully revised, updated and 25% expanded new edition
  • Features new topics such as QbD, Lean, Six Sigma, Basic data analysis, CAPA tools, and Pharma 4.0
  • Includes End of Chapter Summaries and End of Chapter Question and/or Problems
  • Presents real-life case studies from industry
  • Provides detailed steps and examples for applying the guidelines and quality tools
  • Written in an accessible style making the content easy to understand and apply

Readership

Pharmaceutical Manufacturing companies: managerial and supervisory levels; QPs; Bioprocess companies: managerial and supervisory levels; QPs Pharmaceutical Certification Organizations; Industry associations; Technical and academic libraries; Industry training bodies; FDA, EMA, PMDA, WHO, and other governmental agencies

Table of contents

1. Product Life Cycle

2. Elements of Quality Management

3. Quality Systems

4. The Management of Quality

5. Good Manufacturing Practice

6. Validation

7. Good Distribution Practice

8. Technology Transfer

9. Inspection and Auditing

10. Calibration

11. Pharmaceutical Microbiology

12. Water for Pharmaceutical Use

13. Quality Improvement Programmes

14. Corrective and Preventative Action Using Quality Tools and Techniques

Product details

  • Edition: 2
  • Latest edition
  • Volume: 2
  • Published: April 1, 2022
  • Language: English

About the author

KM

Kathleen E. McCormick

Dr. Kate McCormick is a pharmaceutical manufacturing consultant and trainer who has worked extensively with both regulators and companies in more than 50 countries. She is the author of a number of textbooks, and she was an editor of GMP Review and International Education Advisor for ISPE. Dr. McCormick has a degree in biochemistry, a doctorate in microbiology, and is also a Master of Business Administration.
Affiliations and expertise
Pharmaceutical Consultant, Devon, UK