Quality
- 2 Edición, Volumen 2 - 1 de abril de 2022
- Última edición
- Autor: Kathleen E. McCormick
- Idioma: Inglés
Puntos claves
Puntos claves
- 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
De interès para
De interès para
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
Índice
Índice
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
Detalles del producto
Detalles del producto
- Edición: 2
- Última edición
- Volumen: 2
- Publicado: 1 de abril de 2022
- Idioma: Inglés
Sobre el autor
Sobre el autor
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.
Afiliaciones y experiencia
Pharmaceutical Consultant, Devon, UK