Note: We currently are not accepting new certificate registrations for this program. Courses in the existing curriculum will continue to run as scheduled for a limited time, through spring semester 2017.
Build a thorough foundation in the skills and knowledge needed to perform and oversee quality and regulatory compliance functions within the biotechnology industry. In the rapidly growing field of compliance, regulations and guidelines govern the research, development, manufacture and clinical trials process, as well as the marketing and sales of drugs, biologics and medical devices. The Professional Program in Quality and Compliance for Biotechnology reviews Good Pharmaceutical Practice (GXP) principles, procedural guidelines, FDA, and other regulations and ethical considerations. The comprehensive program prepares you for a career in quality assurance, quality control or compliance. The curriculum includes electives drawn from the related functional areas of clinical research, product and process development, manufacturing and supply chain, and regulatory affairs. Many of the required and elective courses apply to multiple programs, allowing you to earn credit while you find the curriculum that's right for you.