“Hot Topic” Courses in Regulatory Science

Three-week, 1-unit “hot topic” courses will be offered beginning Summer 2014!

These are for-credit courses that can meet elective requirements for current students or can be taken for professional development by Regulatory Affairs professionals.

To register for one of the courses listed below, go to Courses-Register for a Course. The cost of each course is $607. For more information, contact Ana Righellis, Program Coordinator, at 619-594-6030.

Regulatory Intelligence/Regulatory Strategy (May 19th – June 8th)
Regulatory intelligence involves gathering, monitoring, analyzing, and communicating regulatory information. This intelligence shapes regulatory strategy for product development and submission routes. This course develops the skills of regulatory affairs professionals to prepare and use regulatory intelligence to develop regulatory strategy recommendations.

GXP Audits (June 9th – June 29th)
GXP audits are conducted to identify non-compliances, but also regulatory weaknesses and the potential for non-compliance. This course familiarizes students with GXP audit activities and helps regulatory affairs professionals develop the skills to participate in the preparation, hosting, and follow-up to GXP audits.

Pre-Approval Inspections (June 30th – July 20th)
Students learn the requirements for hosting successful US FDA Pre-Approval Inspections (PAI) for small and large molecules, how to effectively interpret and apply current Good Manufacturing Practices (cGMPs), and the differences between FDA and EU requirements for the manufacture and control of pharmaceuticals.