Achieving Data Quality and Integrity in Maximum Containment Laboratories — Nonclinical CourseFDA-UTMB Collaborative Education Program

Course Dates: July 28 - August 1, 2025
Manhattan, Kansas

Course Format

In-person (at Bluemont Hotel/ NBAF)

Course Fees

There are no fees associated with course attendance; however, seating for in-person attendance is limited and interested participants will be placed on a wait-list once seats are filled. Travel expenses and meals are incurred at the individual’s expense. Refer to hotel information below.

Course Pre-registration

Whether requesting to attend the course in-person or virtually, course registration is a 3-step process. The first step is to pre-register for the course to indicate your interest in attending. After completing the pre-registration form, you will receive an email with a second link where you will complete a short survey that gathers information on your knowledge and experience. Notification of course admittance will follow, and step 3 is your confirmation of attendance.

2025 Pre-registration Open

The 2025 Nonclinical Course is scheduled for July 28-August 1, 2025, and pre-registration is now open. Use the link below to submit a pre-registration form. For questions, please email us.

 

2025 Pre-Registration Form

Course Description

The four and one-half day training program is offered annually utilizing expert faculty from the U.S. Food and Drug Administration, other government agencies, academia, and business and industry. In-person attendees participate in laboratory activities conducted in mock Biosafety Level (BSL) 2, 3, and 4 training laboratories to emphasize the differences between biosafety levels and the complexity of conducting laboratory activities in a BSL4 laboratory environment.

Target Audience

Scientists, Principal Investigators, Veterinarians, Veterinary Pathologists, Study Sponsors, Contracting Officers, Quality Assurance Personnel, Biosafety Professionals, Physicians, Research Nurses, Graduate Students, Regulators, Agency Reviewers, and Policymakers. 

2025 Planned Course TopicsDays and Titles are Subject to Change

Course Schedule

Course organizers are in the process of finalizing the 2025 course agenda. As a reference, you may wish to view the tentative 2025 course schedule is listed below.

Day 1
8:15 a.m. to 4:30 p.m. CDT
In-person attendees will be required to check-in between 7:45 am – 8:15 am CDT on Monday.

Day 2
8:15 am – 4:30 pm CDT 

Day 3
8:15 am – 4:30 pm CDT 

Day 4
8:15 am – 4:30 pm CDT

Day 5
8:15 am – 12:15 pm CDT 

 

Course Faculty

The Nonclinical Course includes expert faculty from AAALAC, BARDA, Battelle, CEPI, Commonwealth Scientific and Industrial Research Organization (CSIRO - Australia), FDA, NIAID, NIH, Texas Biomedical Research Institute, UK Health Security Agency, USAMRIID, USDA, UTMB, University of Georgia, and other institutions

Prerequisite Knowledge

A basic understanding of the FDA Good Laboratory Practice regulations (21 CFR Part 58) is highly recommended. To meet this need, access to two free online courses will be provided to course attendees. Both courses are submitted for continuing education for quality assurance professionals. The GLP Basic Training course is required for UTMB graduate students seeking academic credit.

  • GLP Basic Training — This twelve (12) self-paced module online course is designed as an introductory course to the U.S. Food and Drug Administration’s Good Laboratory Practice (GLP) regulations (21 CFR Part 58) and includes an  IACUC Essentials module addressing the oversight responsibilities of the Institutional Animal Care and Use Committee (IACUC).
  • GLP Refresher Training (mini course) — This self-paced online course is designed to refresh knowledge for attendees previously familiar with the GLP regulations.

Course Certification, Learning Objectives, and Learning Outcomes

Continuing Education: This course is submitted for Continuing Education credits for nurses, veterinarians, veterinary technicians, biosafety, and quality assurance professionals. Details will be posted closer to course dates.

Certificate of Completion

A certificate of completion will be issued to in-person and virtual attendees who attend the full course. Additional information will be provided upon course admission.

Course Learning Objectives

  1. Determine requirements needed to conduct high quality studies in high/maximum containment laboratories; therefore, enabling efficient approval of MCMs to improve human health.
  2. Identify criteria used to evaluate MCMs in animal models that reflect human disease.
  3. Resolve complexities of performing studies in high/maximum containment under the Animal Rule, including modern methods to comply with data quality standards.
  4. Leverage One Health initiatives to address public health challenges during a pandemic.

Course Learning Outcomes

  1. Apply strategies for assessing data quality and integrity in maximum containment laboratories.
  2. Apply principles of good documentation practices for data collection in studies conducted in maximum containment environments.
  3. Apply strategies in clinical practice to communicate One Health initiatives by using an interdisciplinary approach to address public health challenges faced during a pandemic.

The Nonclinical Course now offers a 2-credit hour graduate course for registered UTMB students.
Please see the Graduate Credit link below.

Graduate Credit - Click to Review

The Nonclinical Course now offers a 2-credit hour graduate course for registered UTMB students.
For more information, click the link above .

Course Location

The course will take place at the Bluemont Hotel in Manhattan, Kansas. Additional hands-on  activities and tour will take place at the National Bio and Agro-Defense Facility (NBAF), for in-person attendees only.   

1212 Bluemont Ave,  
Manhattan, KS 66502 

The Bluemont Hotel offers 112 luxurious guest rooms with more than 7,000 square feet of event space, centrally located in the heart of Manhattan. This property features 50 suite-style rooms, free WiFi and complimentary breakfast. The main floor includes a lobby bar, business center, indoor pool and fitness center. All event space is serviced with food through local caterers, and bar service through the hotel staff. At the corner of Bluemont and Manhattan Avenues, guests have easy access to historic Aggieville and Kansas State University. 

Bluemont Hotel Reservation Information


National Bio and Agro-Defense Facility (NBAF) 
The U.S. Department of Agriculture (USDA) owns and operates the National Bio and Agro-Defense Facility (NBAF) in Manhattan, KS. This state-of-the-art facility is designed to help protect the nation’s agriculture, farmers and citizens against the threat and potential impact of serious animal diseases. NBAF will replace and expand on the mission of the Plum Island Animal Disease Center (PIADC), a biosafety level-3 facility that was established in 1954. Currently, USDA’s Agricultural Research Service (ARS) and Animal and Plant Health Inspection Service (APHIS) conduct foreign animal disease research, training and diagnostics in this center. ARS and APHIS will transfer their missions from PIADC to NBAF and will operate the facility jointly. 


For more information about the mission of NBAF, visit the NBAF Website


Course Hotels — Places to stay while in Manhattan

Click the link above  to view options of places to stay while in Mahattan

Travel to and within Manhattan

Airports & Things To Do 

Manhattan is accessible via two airports Manhattan Regional Airport (MHK - domestic only) within 7 miles, Topeka Regional Airport (FOE - domestic only) within 61 miles and Kansas City International Airport (MCI - domestic and international) within 132 miles.  Transportation from these airports to Manhattan and within Manhattan is best secured by commercial taxi or commercial ride services such as Uber and Lyft. However, as such transportation is rather expensive and sometimes limited, course attendees may instead want to rent a vehicle. A rented vehicle will also support visits to Manhattan sites outside of the Bluemont Hotel. For instance, course visitors may want to plan a short trip to enjoy other sites or many restaurants, or other tourist sites.

Key visitor websites

Course/Event Software Application

Course organizers utilize the WHOVA event management software for hosting the course. A link to the course site will be provided to registered course attendees (both in-person and virtual attendees) approximately 1 week prior to the course start date. Use of the Whova application has been approved for FDA employees.

Frequently Asked Questions

Past Courses

Testimonials

They were all great presentations. I'm happy for the opportunity to take part of this seminar.
– 2024 Course Participant

A great slate of speakers and topics.
– 2024 Course Participant

Excellent and engaging.
– 2024 Course Participant

Excellent mock exercise. This allowed me to have a full understanding of how people navigate the lab in the BSL4 suit and how they view the protocol while in the lab  
– 2024 Course Participant

Great talks. I can tell you that I have gained so much within these few days. Thank you for organizing this!
– 2023 Course Participant

The content was excellent, presenters were incredible, and the A/V team was top notch! I am going to recommend this course to friends/colleagues the next time I see it come up.
– 2023 Course Participant

Being able to attend virtually was fantastic and I hope that the course organizers continue to offer that option in the future.
– 2023 Course Participant

Fantastic opportunity to learn more about studies in high containment.
– 2022 Course Participant

Very interesting in-depth course with lots of challenging information to process. It was great getting hands on experience with the practice suits and to see the facilities and to observe the differences from how we work in the UK.
– 2019 Course Participant

The faculty were knowledgeable and provided relevant and interesting information; the breadth of the presenters was excellent.
– 2019 Course Participant

Highlighted Speakers

Manhattan Highlights


All photos of Manhattan attractions provided courtesy of Visit Manhattan.


Other Scientific Symposiumsnear Manhattan, Kansas

To Be Announced

Need More Information?

Send an email with your question to orncs@utmb.edu