The Management of Chemical Process Development in the Pharmaceutical Industry 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.

The Management of Chemical Process Development in the Pharmaceutical Industry 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 book also covers:

• 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.

Contents

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

Index

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