Monday, October 2 and Thursday, October 5, 2023, 11:30 AM – 4:00 PM CDT
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.
Objectives:
- Identify strategies for efficiently maintaining a select agent or equivalent program in good standing with ongoing requirements, including anticipating areas of emphasis in future inspections and/or future regulatory changes
- Identify strategies for preparing for and responding to regulatory inspections, including strategies to efficiently implement necessary changes.
- Review a series of suitability program case studies and identify strategies for dealing with potential suitability concerns in accompanying exercises
- Summarize inactivation requirements and identify successful strategies for compliance
Suggested Background: None
Target Audience: All Safety Professionals, Select Agent Program Safety Professionals
Audience Level: Intermediate
Course Length: 8 hours (two 4-hour live sessions with a 30-minute break each session)
This webinar will be two 4-hour webinar sessions on Monday, October 2 and Thursday, October 5, 2023, 11:30 AM – 4:00 PM CDT with a 30-minute breaks. For the webinar, you should plan on logging in at 11:15 am (CDT) on October 2 and October 5. You are required to attend the webinar session, complete the pre-course and post course assessments, and complete the evaluation in order to receive the completion certificate through the ABSA International Training Site. The link in the invitation will be unique to the user and cannot be shared.
CONTACT HOURS
This course has been approved for 1.0 CM points toward RBP/CBSP recertification. ABSA International is approved as a provider of continuing education programs in the clinical laboratory sciences by the ASCLS P.A.C.E.® Program. This course is approved for 8.0 P.A.C.E.® contact hours.
COURSE FACULTY
COURSE FEES
Amy Vogler, PhD, RBP is an Associate Director at the Pathogen and Microbiome Institute (PMI) at Northern Arizona University (NAU). She has worked at PMI since 1997 as a researcher and has been responsible for managing their BSL-3 Select Agent laboratory since 2009. She received her B.S. in Microbiology and Chemistry in 1999 and her Ph.D. in Biology in 2003 from NAU and is an author on 40 publications in the field of population genetics and molecular epidemiology of bacterial pathogens. She continues to conduct research on Yersinia pestis while also managing the BSL-3 laboratory. She received her RBP in 2012.
Shelley Jones, MS, RBP, is the Director of Biological Safety and Responsible Official at Northern Arizona University. She received her B.S. from Illinois State University and her M.S. from Arizona State University, both in environmental disciplines. Shelley has over 30 years of diverse experience in environmental health and safety. She has been a Responsible Official/Alternate Responsible Official for 18 years.
ABSA Members: $640 USD (post 9/4 – $690)
Nonmembers: $740 USD (post 9/4 – $790)
To obtain the ABSA member rate, the participant will need to be an ABSA member in the year in which the training is offered. Course fees include: course handouts, access to the ABSA International training site, and 8-hours of interactive instruction from a well-respected subject matter experts.
Confirmed, paid participants will be sent detailed information regarding the course approximately one week prior to the course. Substitutions allowed with notice by 9/7/2023. There is a 15% processing fee for cancellations prior to 9/7/2023. Cancellations between 9/7/2023 and 9/14/2023 will be refunded at 50% of the course fee. No refunds after 9/14/2023.
The links to the various invitations for the course will be unique to the user and cannot be shared. The links are for single, individual use only. If more than one occurrence of an individual’s name is on the attendee list for the webinar through Zoom platform all instances of that person’s name will be removed from the webinar with no refund. The webinar and its associated links are for single, individual use only.
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