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Elsevier

Quality

  • 2 Edición, Volumen 2 - 1 de abril de 2022
  • Última edición
  • Autores: Kathleen E. McCormick, Janet H. Sanders
  • Idioma: Inglés

Puntos claves

  • Fully revised, updated, and expanded new edition
  • Features new topics such as QbD, Lean, Six Sigma, basic data analysis, and CAPA tools
  • Includes end-of-chapter summaries and end-of-chapter question and/or problems
  • 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

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

1. Product Life Cycle

2. Good Manufacturing Practice

3. Elements of Quality Management

4. Quality Systems and International Standards

5. The Management of Quality

6. Inspections and Auditing

7. Quality Improvement Programmes

8. Corrective and preventive actions

9. Calibration

10. Validation

11. Technology Transfer

12. Water for Pharmaceutical Use

13. Pharmaceutical Microbiology

14. Good Distribution Practice

Detalles del producto

  • Edición: 2
  • Última edición
  • Volumen: 2
  • Publicado: 1 de abril de 2022
  • Idioma: Inglés

Sobre los autores

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

JS

Janet H. Sanders

Janet H. Sanders is an Associate Professor in the Department of Technology Systems at East Carolina University where her research focus includes quality, statistics, Lean Six Sigma, and process improvement methodologies. She has a BS in Ceramic Engineering, MS in Industrial Management, and a PhD in Industrial Engineering, and 30+ years of process improvement experience in various manufacturing, service, and healthcare industries.
Afiliaciones y experiencia
Associate Professor, East Carolina University, USA

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