Nonclinical Course FDA-UTMB Collaborative Education Program

Achieving Data Quality and Integrity in Maximum Containment Laboratories

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!

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

    2. 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.

    3. 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

    • 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

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    Frequently Asked Questions

    Registered Attendees

    Pre-registration and Course Admittance

    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