Nonclinical Course FDA-UTMB Collaborative Education Program

Achieving Data Quality and Integrity in Maximum Containment Laboratories

FDA-UTMB Collaborative Education Program

Pre-registration is now closed.

Please reach out to orncs@utmb.edu with any questions about pre-registration.

Course Details & Registration

Course Dates
April 20-24, 2026

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 Closed
Course registration is a two-step process. First, complete the pre-registration form to indicate your interest in attending. If selected, you will receive an official invitation from the University of Texas Medical Branch with instructions to confirm your attendance. 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.

Course Description

The four-and-a-half-day training program is offered annually and features 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 highlight the differences between biosafety levels and the complexity of conducting laboratory activities in a BSL-4 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.

Planned Course Topics

Exciting new topics!

  1. Use of AI for MCM Development
  2. Applying GLP Principles to Studies Conducted on the International Space Station (ISS)
  3. Assay Qualification and Validation
  4. New Approach Methodologies (NAMs)
  5. Microphysiological Systems (Organs on a chip)
  6. Communicating Science to Stakeholders and the General Public

Course Schedule

Course organizers are in the process of finalizing the course agenda. As a reference, you may wish to view the tentative 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, UTMB, CEPI, New Iberia Research Center, NASA, Rhodium Scientific, CDER, DTRA, Boston University’s NEIDL, FDA, NIAID, NIH, Texas Biomedical Research Institute, USAMRIID, USDA, University of Georgia, and other non-profit agencies, universities and 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.

Course Location

The course will take place at the University of Texas Medical Branch in Galveston, Texas. See hotel and travel information.

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.

2026 Highlighted Speakers

Portrait of Dr. Anne  Rimoin

Dr. Anne Rimoin

Portrait of Dr. Gene  Olinger

Dr. Gene Olinger

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


Frequently Asked Questions

Pre-registration and Course Admittance

Registered Attendees

Further Inquiries

If you do not find an answer to your question, please send your inquiry to orncs@utmb.edu.

Past Courses

Course History by Year

2026
April 20-24, 2026
The University of Texas Medical Branch
Galveston, Texas, USA
Hybrid

2025
July 28 - August 1, 2025
National Bio and Agro-Defense Facility
Manhattan, Kansas, USA

2024
April 15 - 19, 2024Health Education CenterThe University of Texas Medical Branch
Galveston, Texas, USA

2023
April 24 - 28, 2023
Bethesda, MD, USA
The Bethesdan Hotel
Hybrid

2022
April 25 - 29, 2022
Bethesda, MD, USA
The Bethesdan Hotel
Hybrid

2021
June 15 - 18, 2021
Live Virtual

2020
Postponed until the summer of 2021 due to COVID-19 pandemic
Bethesda, MD, USA

2019
April 8 - April 12, 2019
National Institutes of Health (NIH)
Bethesda, MD, USA

2018
April 23 - April 27, 2018
Natcher Conference Center
National Institutes of Health (NIH)
Bethesda, MD, USA

2017
April 24 - April 28, 2017
Natcher Conference Center
National Institutes of Health (NIH)
Bethesda, MD, USA

 

2016
April 25 - April 29, 2016
Natcher Conference Center
National Institutes of Health (NIH)
Bethesda, MD, USA

2015
April 27 - May 1, 2015
Natcher Conference Center
National Institutes of Health (NIH)
Bethesda, MD, USA

2014
April 28 - May 2, 2014
Natcher Conference Center
National Institutes of Health (NIH)
Bethesda, MD, USA

2013
Pilot Course
April 1 - 5, 2013
Galveston National Laboratory
The University of Texas Medical Branch,
Galveston, TX, USA