5V. Keeping it Going: Maintaining and Improving a Select Agent Program over the Long Term
Keeping a select agent program going can be difficult, especially in the face of ever-changing regulatory requirements and limited resources. Established procedures may suddenly become unacceptable, interrupting research, and frustrating laboratorians. Likewise, a single unexpected adverse event can put an entire program at risk. Being prepared to deal with such changes and events is critical to maintaining a robust program. Anticipating future challenges can be even more advantageous, elevating a program from good to great. A proactive approach can minimize the impact of new requirements and reduce duration and frequency of crises sparked by sudden, unexpected requirements or events. This course will explore strategies for maintaining and improving an existing program, including how to anticipate and respond to new requirements. The focus will be on U.S. select agent requirements, although a small section on comparable requirements in the international community will be included. Strategies will be based on the instructors’ experience with their program with additional input solicited from class participants during open discussions. Topics will include select agent program history; effective oversight; efficiently meeting ongoing requirements; reporting, responding to, and analyzing incidents; suitability program case studies; inactivation requirements, including “failure” investigation; and inspection preparation and response. The course will consist of topical presentations followed by group discussions aimed at facilitating application of presented strategies to participants’ individual programs and providing a platform to capitalize on participants’ collective experience.

