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