Quality
- 2nd Edition, Volume 2 - April 1, 2022
- Latest edition
- Author: Kathleen E. McCormick
- Language: English
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Key features
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
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
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
Product details
- Edition: 2
- Latest edition
- Volume: 2
- Published: April 1, 2022
- Language: English
About the author
About the author
KM