The Management of Chemical Process Development in the Pharmaceutical Industry (eBook)

Derek Walker (Autor)

eBook Download: PDF

2008 | 1. Auflage
424 Seiten
John Wiley & Sons (Verlag)
978-0-470-25950-4 (ISBN)

Infos

Here is a practical guide that not only presents insights into the
organization and management of the disciplines involved in chemical
process development but also provides basic knowledge of these
disciplines, enabling process development practitioners to
recognize and assimilate them in their work. This book illustrates
practical considerations through many examples of the successful
direction and integration of the activities of chemists, analysts,
chemical engineers, and biologists, as well as safety, regulatory,
and environmental professionals in productive teams. Moreover, this
reference provides guidance on:

* Directing and carrying out specific tasks and courses of
action

* Making and communicating clear and achievable decisions

* Solving problems on the spot

* Managing the administrative aspects of chemical process
development

The author, Dr. Derek Walker, has directed chemical process
development work for four decades, combining firsthand chemical
synthesis experience with many other disciplines needed to create
chemical processes. You will benefit from his advice and unique
insights 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 motivating
staff

* Prioritizing programs and responses to emergencies

In addition, you'll learn how successful chemists, in
collaboration with other disciplines, define the best (green)
chemistry for process scale-up, including accommodating FDA
requirements in the last process steps and addressing safety and
environmental matters early in their work. Case studies provide
incisive perspective on these issues. A chapter on recognizing and
patenting intellectual property emphasizes the importance of
comprehensive literature surveys and understanding invention. A
chapter on the future challenges you to think beyond narrow
constraints and explore new horizons.

Autor

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.

Inhalt

1. Introduction.

2. People: Leadership, Visionaries, Acknowledgements and
Awards.

3. Organisation.

4. Process Safety.

5. The Environment.

6. Regulatory Affairs: Meeting the U.S. Food and Drug
Administration (Fda) Requirements.

7. Patents.

8. Chemical Engineering.

9. Excursions in The B-Lactam And Steroid Fields.

10. Case Studies.

11. The Future.

Rezensionen

"A useful addition to the library of any process development
chemist or engineer ... .Highly readable." (Chemistry
World, November 2008)

"Interesting reading ... A nice overview of subject matter
such as process safety, the environment, regulatory affairs and
patents." (Scientific Update, September 2008)

"Derek Walker has distilled his 40 years of experience in
process development in the pharma industry in one book." (TCE -
The Chemical Engineer, May 2008)

Produkt-Details

• Erscheint lt. Verlag: 13.3.2008
• Sprache: englisch
• Themenwelt: Medizin / Pharmazie
• Themenwelt: Naturwissenschaften ► Chemie
• Themenwelt: Technik
• Schlagworte: Betriebswirtschaft • Betriebswirtschaft u. Operationsforschung • Business & Management • chemical engineering • Chemische Verfahrenstechnik • Management Science/Operational Research • process development • Verfahrensentwicklung • Wirtschaft u. Management
• ISBN-10: 0-470-25950-7 / 0470259507
• ISBN-13: 978-0-470-25950-4 / 9780470259504