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!
- 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
Course Schedule
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
- Determine requirements needed to conduct high quality studies in high/maximum containment laboratories; therefore, enabling efficient approval of MCMs to improve human health.
- Identify criteria used to evaluate MCMs in animal models that reflect human disease.
- Resolve complexities of performing studies in high/maximum containment under the Animal Rule, including modern methods to comply with data quality standards.
- Leverage One Health initiatives to address public health challenges during a pandemic.
Course Learning Outcomes
- Apply strategies for assessing data quality and integrity in maximum containment laboratories.
- Apply principles of good documentation practices for data collection in studies conducted in maximum containment environments.
- 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
Dr. Anne Rimoin
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
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What fees are associated with attending this course?
No! The course is funded by an educational grant through the U.S. Department of Health and Human Services Food and Drug Administration (FDA). In-person attendees will be responsible for expenses related to travel. The only exception is if you are a UTMB graduate student seeking graduate credit.
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What are the differences between pre-registration and course admittance?
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 admitting you to the course. 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.
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What should I do if I have not heard whether I have been accepted into the course? I already submitted my pre-registration information.
First, please check your Spam folder to be sure that the email has not been blocked by a firewall. If you have not received notification after 30 days of pre-registration, please send an email to orncs@utmb.edu. If you need to inquire on the status of your application in order to make travel reservations, you may also send an email to orncs@utmb.edu.
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As a UTMB graduate student, I would like to take this course and earn graduate credit. Do I need to register online (ORNcS course website) and through the graduate school?
Yes, please proceed with the pre-registration process and indicate that you are a graduate student. There are no fees associated with this process. You will also need to signup for the course and remit payment through the internal process.
Registered Attendees
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I have a colleague who will benefit from this knowledge. Can I share the meeting link with them?
We are happy to hear that the content is relevant; however, we must track all attendees. If your colleague would like to have access, please email a request to orncs@utmb.edu and someone will contact them directly.
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As an in-person attendee, is it also possible to attend some lectures virtually?
As there are a smaller number of individuals admitted for in-person attendance, in-person attendees are kindly reminded that someone else may be on a waiting list to be admitted. If there are unusual circumstances that require flexibility, please email your request to orncs@utmb.edu and course organizers will do their best to accommodate.
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I registered and was admitted to the course to attend in-person. What should I do if I am unable to attend?
Please send an email to orncs@utmb.edu as soon as possible. Course organizers can switch you from in-person attendance to virtual if you are still available to attend. Additionally, we can release your in-person seat to someone on the waiting list. The deadline to switch is 30 days prior to the course start date (March 20, 2026).
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Will I be able to submit questions to the presenters virtually?
Yes! There will be a mechanism for submitting your questions. Instructions will be shared on the first day of the course.
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Will I receive a certificate of completion?
Yes, a certificate will be provided for those who attended the course in its entirety. We closely monitor online attendance for this purpose. For attendees seeking full or partial Continuing Education (CE) credits, instructions will be provided during and after the course. For virtual attendees, please assure you are consistently using the same name (first and last) and email for registration and course participation. If you experience an emergency that impacts your ability to participate fully, please email the course organizers at orncs@utmb.edu.
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Will I be able to get a course certificate if I am unable to attend the entire course (in-person or virtual)?
Please email the course organizers at orncs@utmb.edu and someone will contact you. If you will miss the majority of the course, you can be placed on a priority list for the 2025 course. If you will only miss a few sessions, we can provide instructions for claiming partial CE credits.
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If I am registered to attend virtually, can I participate in the hands-on activities and tour the Galveston National Laboratory (GNL)?
These activities are reserved for in-person attendees. You can make a special request by emailing orncs@utmb.edu; however, please note that it is unlikely course organizers will be able to accommodate this request. Capacity is limited for the mock BSL4 laboratory activity and there are security screening requirements that must be met several weeks in advance prior to taking the tour of the NBAF. Please make this request as early as possible.
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I need a visa to enter the United States to attend this course. Does the course provide visa sponsorship?
You may use your course invitation and the meeting website to help support your request. If you require any further written documentation, please email your request to orncs@utmb.edu. Course organizers will try to accommodate by providing additional information as needed; however, we are unable to contact the respective Consulate directly. Please note that no financial assistance is available to offset travel expenses.
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Will continuing education credit be offered to course attendees?
Yes. Course organizers submit applications to certify the course for Continuing Nursing Education, Registered Quality Assurance Professionals (RQAP), RACE (for veterinarians and techs), and ABSA Registered Biosafety Professionals (RBP/CBSP) credentialing maintenance (CM) credits. Once the course is approved, the accreditation information will be posted on the course website and Whova (course management application). Instructions on how to claim credit will be provided at a later date.
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After registering, when can I expect to receive additional course information?
All registered attendees will receive an email approximately one week prior to the course start date that will contain additional information and instructions. If you do not receive information, check this website for general announcements or email orncs@utmb.edu.
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Will I need to download any applications before attending the course?
The course will be administered through the WHOVA event management platform. Instructions will be provided on how to access the course. UTMB has received authorization by FDA IT for use by FDA employees. For virtual attendees, lectures will be provided in Whova. Whova will have embedded streaming links through Zoom. Please ensure you can access Zoom. IF YOU ARE NOT ABLE TO DOWNLOAD THE WHOVA APPLICATION, please notify Katherine Rosen at kerosen@utmb.edu.
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I did not select an online GLP course during pre-registration but would now like to take one. How can I register?
Please email your first and last name along with your email address to orncs@utmb.edu and indicate if you would like to take the Basic GLP course (12 modules) or the GLP Refresher mini course (1 module). Course organizers will assure you are given access.
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I indicated that I am interested in taking an online GLP course. When will I receive access, and how long will the course be available to me?
You will receive an email from UTMB@Reach360.com with access information. Access will be granted for approximately six weeks starting 1-2 weeks prior to the course start date.
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Will presentation slides be available to course attendees?
Presentations will be provided after the course for sessions where faculty provided consent to release. Some information may be redacted.
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Will course sessions be recorded and made available to attendees?
No, sessions will not be recorded for the purpose of viewing by course attendees. Some sessions may be recorded to aid in future course development.
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As an in-person attendee, do I need to physically sign in each day if I am also signing in through the Whova app?
Yes, please physically sign in as you arrive each day.
Further Inquiries
If you do not find an answer to your question, please send your inquiry to orncs@utmb.edu.