Introduction
The field of research and development is changing workforce requirements of maturing biotechnology companies. New and different skills are required as companies make the transition from primarily research and development organizations to more fully integrated operations with clinical, regulatory, manufacturing and product commercialization functions.

The following programs provide the knowledge and skills for companies and individiuals to meet these new challenges of the biotechnology and related industries.

The Certificate Program is delivered in collaboration with The center for Bio/Pharmaceutical and Biodevice Development at San Diego State University. The certificate program provides a background in laws and regulations mandated by the federal government, especially the Food and Drug Administration, pertaining to the development, testing, aproval, manufacturing, commercialization, and post–marking surveillance of pharmaceutical, biopharmaceutical and biodevice products.

Throughout the program, emphasis is placed on having a detailed knowledge and understanding of current regulations with practical application to the development and commercialization of drug, biologic, and biodevice products. Each course is ten weeks long.

Contact Info
For additional information, contact Rich Caramella, Program Director, Division of Extended and Continuing Education at 510.881.2312 or e-mail rcaramel@csuhayward.edu.

California State University, Hayward
Department of Biological Sciences
Hayward, California 94542-3090