Risk management principles are widely used to identify and develop strategies to minimize risks related to products, processes and services. More than just a valuable skill set, risk management is now essential in product and process design and implementation. This course provides an in-depth look at risk management with a focus on how it is applied in the medical device, biotechnology, pharmaceutical and in vitro diagnostic (IVD) industries. Students explore the common risk-identification and risk-reduction methods applicable to biomedical industries, which are also relevant to many other industries. Lectures and interactive workshop sessions delve into the major risk management concepts and tools, including hazard analysis, fault tree analysis, failure modes and effects analysis (FMEA), mitigation application, and regulatory requirements. The instructor will explain how to create a risk management report and build and maintain a risk management file. Assignments and in-class activities will be used to guide students through the creation of their own risk management file. By the end of the course, students will be able to conduct competent and complete risk management for a variety for products, processes and services within the biomedical industries and beyond.
Instructor: BARRY CRANER, M.A., M.B.A.,CQE, CRE, CQA and CBA
6pm-9:15pm, Jun 14, 2010 to Aug 30, 2010 (no meetings on July 5 and August 2).
To enroll, visit:
www.ucsc-extension.edu/programs/medical-devices/courses
and then select course title
