Series Description

The FDA Grand Rounds highlights cutting-edge research underway across the agency and its impact on protecting and advancing public health. Each session features an FDA scientist presenting on a key public health challenge and how FDA is applying science to its regulatory activities.

Lecture Description
Whole Genome Sequencing has been used in FDA's Human and Animal Food Laboratories for several years, but what about in the medical products laboratories? This presentation will discuss the application of this method as an additional analysis used during the 2023 Pseudomonas outbreak in eye drop products. ORS' collaboration with the CDC and CFSAN partners led to key information that linked the outbreak strain to the implicated products, providing a scientific basis for FDA to pursue regulatory action.

References

• Bear, R., Rintoul, D., Snyder, B., Smith-Caldas, M., Herren, C., & Horne, E. (2016). Principles of Biology: Taxonomy and Phylogeny.
• Davis, S., Pettengill, J. B., Luo, Y., Payne, J., Shpuntoff, A., Rand, H., & Strain, E. (2015). CFSAN SNP Pipeline: an automated method for constructing SNP matrices from next-generation sequence data. PeerJ Computer Science. https://doi.org/10.7717/peerj-cs.20/supp-1
• Pightling, A. W., Pettengill, J. B., Luo, Y., Baugher, J. D., Rand, H., & Strain, E. (2018). Interpreting Whole-Genome Sequence Analyses of Foodborne Bacteria for Regulatory Application and Outbreak Investigations. Frontiers in Microbiology. https://doi.org/10.3389/fmicb.2018.01482

Series Objectives

• Discuss the research conducted at the FDA
• Explain how FDA science impacts public health

Learning Objectives After completion of this activity, the participant will be able to:

• Define whole genome sequencing and state its basic purpose.
• Describe how whole genome sequencing can determine relatedness among isolates.
• Discuss how whole genome sequencing was used to link the implicated products to the outbreak strain during the 2023 Pseudomonas outbreak in eyedrops.

Target Audience
This activity is intended for physicians, pharmacists, nurses, and other scientists within the agency and external scientific communities.

Registration Information
Registration is complimentary; therefore refunds are not applicable. For information on how to register to attend this activity, please contact the Activity Coordinator(s) listed above.

Requirements for Receiving CE Credit

All learners claiming credit must attest to their attendance and complete all required activity evaluation(s) in the FDA CE Portal (ceportal.fda.gov) within 14 days after an activity ends. Upon completion, learners may view/print statement of credit.

Attention NABP Pharmacists and Pharmacy Technicians: The FDA CE Team will report your credit to the National Association of Boards of Pharmacy (NABP) provided you add your NABP ID and date of birth to your profile in the FDA CE Portal. The only official Statement of Credit is the one you pull from CPE Monitor. If you do not see your credit reflected on CPE Monitor* after 45 days of attestation, please contact FDACETeam@fda.hhs.gov. *CPE Monitor sets a strict 60-day limit on uploading credits.

Disclosure

Faculty

• Cockrell, Michelle, BS, Microbiologist, FDA/ORA/ORS/OMPSLO/IRVLMP - nothing to disclose

Planning Committee

• Dinatale, Miriam, DO, Team Leader, Food and Drug Administration - nothing to disclose
• Pfundt, Tiffany, PharmD, Program Coordinator, FDA/CDER/OTBB - nothing to disclose
• Shahidzadeh, Rokhsareh, RN, MSN, Senior Regulatory Health Education Specialist, FDA - nothing to disclose

CE Consultation and Accreditation Team

• Faberlle, Alexandra M., Training Specialist / FDA/CDER/OEP/DLOD - nothing to disclose
• Bryant, Traci, M.A.T., Lead Training Specialist, FDA/CDER/OEP/DLOD - nothing to disclose
• Wood, Sara, Accreditation Program Administrator, CECAT, FDA/CDER/OEP/DLOD - nothing to disclose