The outsourcing of manufacturing and other processes in pharmaceutical research and development is rapidly growing. With this growth, several high-profile safety issues have occurred which have been directly linked to poor supplier controls. The FDA has indicated that it will increase its scrutiny of control and evaluation of suppliers in the industry. Learn the best practices for setting appropriate controls for suppliers based on risk and developing assessment methods and continuous monitoring tools. The course is intended for individuals wishing to understand supplier selection, evaluation, or monitoring. Sample assessment tools will be provided to the students.
Course Number: BIOL-40257 Credit: 3 units