||In the 21th century, the bio-technological industry has been the important industry in the world. It is also the most emergent sunrise industry following the electronics industry in Taiwan. The bio-technological industry is very different from the other technological industries. The biological products intended for human therapeutic use have to face the needs of safety and efficacy except product quality. Taiwan government and other countries have established the regulatory framework for biological products to ensure their safety and efficacy. Therefore, the realization of the management system for biological products is very useful to industry development.
This course uses the examples of vaccines, blood products, recombinant DNA products, diagnostic devices and human cell and tissue-based products to introduce the design control, quality control, process control, evaluation for safety and efficacy and regulatory framework in Taiwan. The course also discusses the issues of fac