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

Pre-registration Now Open

Course Dates: April 20-24, 2026
Galveston, TX

Registration Deadlines:
In-person: March 15, 2026 or Virtual: March 31, 2026

Course Flyer

Course Format

In-person (at UTMB Galveston) and virtual

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 waitlist once seats are filled. Travel expenses and meals are incurred at the individual’s expense. Refer to hotel information below.

Course Pre-registration NOW OPEN

Course registration is a 2-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 official invitation to the course via email from the University of Texas Medical Branch. Please allow up to 30 days to receive an official invitation to the course. Your course registration is not complete until you receive a course invitation. 

For questions about pre-registration, please email us.

 

The 2026 Nonclinical Course is scheduled for April 20-24, 2026

Pre-Registration Form

For questions about pre-registration, please email us.

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. 

2026 Planned Course Topics

Exciting new topics to be announced.
Days and Titles are Subject to Change

Course Schedule

Course organizers are in the process of finalizing the 2026 course agenda. As a reference, you may wish to view the tentative 2025 course schedule 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 University of Texas Medical Branch in Galveston, Texas. 

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

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Past Courses

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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

2026 Highlighted Speakers

Exciting new changes to the speaker lineup to be announced. Check back soon!

Other Scientific Symposiums

To Be Announced

Need More Information?

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

Please reference "Nonclinical Course" in Email Subject Title.