Biotechnology and Bio-Processes
Class Schedule
Online Class - Drug discovery research has shifted away from a chemistry-based product development cycle to a more biology-based approach. In the drug development process, it is crucial that engineers are aware of and adhere to basic principles contained in biological processes. Understanding the behavior of individual molecules in disease-causing organisms, learning how the body reacts to certain drugs, how long a drug must remain in the body to be effective, and the development of new and cost effective vaccines, are some of the issues pertinent to drug development and delivery. This class will give the student an introduction to the biological processes specific to this development, including cell biology, biochemistry and the principles of contamination, sterilization, and fermentation. Recent studies in stem cell research (principles, ethics and social issues), cloning and human genome project will be introduced. An introduction to nanotechnology and nanomedicine will be covered.
|
Process Engineering in the Pharmaceutical Industry
Class Schedule
Online Class - Process engineering processes materials through different manufacturing operating processes to convert them into products with desired specific attributes. The goal is to maintain and improve the efficiency, safety, cleanliness, and economy of the processes. Topics include manufacturing operations and plant processes, process control, instrumentation issues and materials engineering.
|
Facilities Design and Maintenance
Online Class - Learn about the design, construction and management of pharmaceutical and biotech facilities. Examine the requirements for design and construction of the complete adaptable manufacturing facility. Develop requirements and gather data for a small-scale pharmaceutical manufacturing facility to illustrate how such facilities can be designed and maintained. Topics include water systems, critical utilities, "cleanrooms" and process equipment design.
|
Validation and Verification
Online Class - Process validation has been a legal requirement in the pharmaceutical industry for over two decades. You will gain theoretical and practical information pertaining to validation of processes involved in the manufacturing of pharmaceutical products with focus on sterile manufacturing processes. The class objective is to present information conducive to a better understanding of this demanding process. You will be better prepared to establish process equipment evaluation and validation programs on a sound basis.
|
Regulatory Affairs and Quality Assurance in the Pharmaceutical Industry
In this online class, you will learn how to meet the challenge of maintaining compliance with Federal regulations and the FDA's expectations. You will be introduced to Federal Regulation 21CFR211 and the Current Good Manufacturing Practices of Finished Pharmaceuticals with respect to drug manufacturing. Learn about the FDA perspective on regulations and guidance practices as well as current areas targeted by the FDA. Gain practical knowledge of GMP applications as related to real-world operations and quality issues as well as current FDA requirements.
|