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The Management of Chemical Process Development in the Pharmaceutical Industry

The Management of Chemical Process Development in the Pharmaceutical Industry

Derek Walker

ISBN: 978-0-470-25951-1

Aug 2007

424 pages


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.

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.

""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)