Walker The Management of Chemical Process Development in the Pharmaceutical Industry

1. Auflage 2008
ISBN: 978-0-470-25950-4
Verlag: John Wiley & Sons
Format: PDF
Kopierschutz: Adobe DRM (»Systemvoraussetzungen)

E-Book, Englisch, 424 Seiten, E-Book

Here is a practical guide that not only presents insights into theorganization and management of the disciplines involved in chemicalprocess development but also provides basic knowledge of thesedisciplines, enabling process development practitioners torecognize and assimilate them in their work. This book illustratespractical considerations through many examples of the successfuldirection and integration of the activities of chemists, analysts,chemical engineers, and biologists, as well as safety, regulatory,and environmental professionals in productive teams. Moreover, thisreference provides guidance on:
* Directing and carrying out specific tasks and courses ofaction
* Making and communicating clear and achievable decisions
* Solving problems on the spot
* Managing the administrative aspects of chemical processdevelopment
The author, Dr. Derek Walker, has directed chemical processdevelopment work for four decades, combining firsthand chemicalsynthesis experience with many other disciplines needed to createchemical processes. You will benefit from his advice and uniqueinsights into:
* Understanding the workings of matrix organizations
* Defining missions and creating action plans
* Developing interdisciplinary approaches to problem solving
* Holding review meetings, revising goals, and motivatingstaff
* Prioritizing programs and responses to emergencies
In addition, you'll learn how successful chemists, incollaboration with other disciplines, define the best (green)chemistry for process scale-up, including accommodating FDArequirements in the last process steps and addressing safety andenvironmental matters early in their work. Case studies provideincisive perspective on these issues. A chapter on recognizing andpatenting intellectual property emphasizes the importance ofcomprehensive literature surveys and understanding invention. Achapter on the future challenges you to think beyond narrowconstraints and explore new horizons.

Autoren/Hrsg.

Walker, Derek

Inhaltsverzeichnis

1. Introduction.
2. People: Leadership, Visionaries, Acknowledgements andAwards.
3. Organisation.
4. Process Safety.
5. The Environment.
6. Regulatory Affairs: Meeting the U.S. Food and DrugAdministration (Fda) Requirements.
7. Patents.
8. Chemical Engineering.
9. Excursions in The B-Lactam And Steroid Fields.
10. Case Studies.
11. The Future.

Über Autor(innen)

Derek Walker, PhD, has distilled the experience of over forty years' work, with publications or patents in every one of the last six decades, into this book. After brief periods with the United Kingdom Atomic Weapons and Research Establishment and Dominion Tar and Chemical Company in Canada, he commenced his career in the development of chemical processes in the pharmaceutical industry through employment with Arapahoe Chemicals/Syntex, Glaxo Laboratories, Bristol-Myers, and finally Schering-Plough Research Institute, where he was vice president of chemical process development for fourteen years.