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

Registration

Course Dates: April 15 - 19, 2024

Course Format

In-person (at UTMB) or 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 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.

2024 Pre-registration is closed. For questions, please email orncs@utmb.edu

In-person Pre-registration is closed

Virtual Pre-registration is closed

2024 Nonclinical Course Flyer

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.

2024 Planned Course TopicsDays and Titles are Subject to Change

2024 Planned Course Topics  - Non-Clinical

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  • Day 1

    Day 1

    • Clinical Research at the Ebola Virus Disease Bedside
    • Regulatory Mechanisms to Facilitate Development/Approval/Licensure of Medical Countermeasures
    • Animal Rule and Product Development
    • Data Standards for Animal Rule Studies
    • FDA Inspections--Data Quality and Integrity Audits
    • Operationalizing BSL-4 in the Field
  • Day 2

    Day 2

    • Pivotal Studies for NIAID Sponsored Animal Model Development
    • Quality System Expectations for BARDA-sponsored studies
    • Defining the Differences Between BSL-2, BSL-3, and BSL-4 Facilities
    • Managing Equipment
    • Quality Assurance Auditing in BSL-4 laboratories
    • The Role of Testing Facility Management
    • The Role of the Study Director
    • Applying One Health Principles for Outbreak Response
  • Day 3

    Day 3

    • Life in a BSL-4 Suit
    • Development, Characterization and Standardization of Bacterial and Viral Stocks
    • Animal Models for COVID
    • Protocol Experimental Design and Approval
    • Animal Use Supportive Care and Clinical Records
    • The Study Director vs. the Attending Veterinarian
    • Telemetry Concepts and Demonstration
    • Communicating Pathology Findings Effectively in Regulatory Submissions to the FDA
    • Animal Welfare Regulatory Requirements and Standards
  • Day 4

    Day 4

    • Unforeseen Circumstances: Emergency Response in BSL-4 Laboratories
    • Aerosol Systems - Aerobiology with High Containment
    • The Role of the USDA National Bio and Agro-Defense Facility (NBAF)
    • Biosafety Requirements During Inspectional Activities
    • Interactive Exercises in a Mock BSL-4 Training Laboratory
    • BSL-4 Lab Tour
  • Day 5

    Day 5

    • Regulatory in Vivo: U.K. Perspective
    • Global Responses to the COVID Pandemic
    • Public Health Emergencies and Data Quality: Your Data Can Save Lives
    • Conducting Clinical Research in the Setting of an Outbreak: From HIV to Ebola to COVID-19

Course Schedule

Course organizers are in the process of finalizing the 2024 course agenda. As a reference, you may wish to view the 2023 agenda . The tentative 2024 course schedule is listed below.

In-person attendees will be required to check-in between 8:00 am – 8:30 am CDT on Monday, April 15, 2024.

April 15 – 18, 2024
8:30 am – 4:30 pm CDT

April 19, 2024
8:30 am – 12:30 pm CDT

Course Faculty

The Nonclinical Course includes expert faculty from AAALAC, BARDA, Battelle, CEPI, FDA, NIAID, NIH, MRI Global, Pfizer, Texas Biomedical Research Institute, UK Health Security Agency, USAMRIID, USDA, UTMB, Yale University School of Medicine 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, 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 in the UTMB Health Education Center (HEC) with additional activities in the UTMB mock BSL4 training laboratory. A tour of the Galveston National Laboratory is included for in-person attendees.

UTMB Health Education Center 
301 11th Street
Galveston, TX USA 77550

The Health Education Center (HEC) is a 161,000 square foot, five story facility located on the University of Texas Medical Branch (UTMB) campus in Galveston, Texas. For more than 130 years UTMB has been dedicated to training today and tomorrow’s healthcare workforce. The HEC is home to three core, centralized UTMB resources: The Interprofessional Simulation Center, the Office of Interprofessional Education, and the Office of Life Support Education and Training. Within the HEC, learners practice and develop skill proficiency required for team-based, safe, quality patient-centered care using evidence-based methodologies and state-of-art-technology. 

Galveston National Laboratory

The Galveston National Laboratory (GNL) is a sophisticated high containment research facility that serves as a critically important resource in the global fight against infectious diseases. The GNL is located on the campus of the University of Texas Medical Branch and operates under the umbrella of UTMB’s Institute for Human Infections and Immunity.

Course Hotels — Places to stay while in Galveston

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

Travel to and within Galveston

Galveston is accessible via two airports (William H. Hobby Airport within 40 miles and George Bush Intercontinental Airport within 70 miles) with both supporting domestic and international travelers. Transportation from these airports to Galveston and within Galveston is best secured by commercial taxi or commercial ride services such as Uber and Lyft. However, as such transportation is rather expensive, course attendees may instead want to rent a vehicle. A rented vehicle will also support their visits to Galveston sites outside of Moody Gardens. For instance, course visitors may want to plan a short trip to enjoy the beach or to visit Galveston’s downtown area, many restaurants, or other tourist sites:

https://www.galveston.com/trip-planning/areas/downtown/

https://www.galveston.com/

www.fly2houston.com/

https://discoverymap.com/galveston-tx

Galveston Limousine operates a shuttle to Galveston from both airports.

https://galvestonlimo.com/

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

Frequently Asked Questions (FAQ) - Non-Clinical

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  • Pre-registration and Course Admittance

    Q1: Are there any fees associated with attending this course?

    A1: 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.

    Q2. What is the difference between pre-registration and course admittance?

    A2: Admittance to the course, whether attending in-person or virtually, is a 3-step process. While course organizers try to accommodate all requests, the total number of attendees is limited; therefore, admittance is based on availability. After completion of Steps 1 and 2, you will be notified if you have been admitted to the course. Please allow up to 30 days for the admissions process. Step 3 is your acceptance to the course invitation. Upon admission, you will receive additional information.

    Q3. I submitted my pre-registration information, but I have not yet heard whether I have been accepted into the course. What should I do?

    A3: 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 from completing Steps 1 and 2 of the pre-registration process, please send an inquiry 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.

    Q4: I am a UTMB graduate student that would like to take this course and earn graduate credit. Do I need to register online (ORNcS course website) and through the graduate school?

    A4: 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

    Q5: I am attending the course and have a colleague who will benefit from this knowledge. Can I share the meeting link with them?

    A5: 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.

    Q6: I am attending the course in-person. Is it possible to attend some lectures in-person and some virtually?

    A6: 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.

    Q7: I registered and was admitted to the course to attend in-person; however, I am now unable to attend in-person. What should I do?

    A7: 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.

    Q8: I am attending the course virtually. Will I be able to submit questions to the presenters?

    A8: Yes! There will be a mechanism for submitting your questions. Instructions will be shared on the first day of the course.

    Q9: Will a certificate of completion be provided?

    A9: 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.

    Q10: If I am unable to attend the entire course (in-person or virtual), will I be able to get a course certificate?

    A10: 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.

    Q11: I am registered to attend the course virtually; however, can I attend the mock BSL4 laboratory activities and tour the GNL?

    A11: 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 GNL. Please make this request as early as possible.

    Q12: I will need a VISA to enter the US to take this course. Will you provide any sponsorship?

    A12: 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.

    Q13: Will Continuing Education credit be available for attendees?

    A13: Yes. Course organizers submit applications to certify the course for Continuing Nursing Education, Registered Quality Assurance Professionals (RQAP), RACE, 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.

    Q14: I am registered to attend the course, when can I expect to receive additional course information?

    A14: All registered attendees will receive an email approximately one week prior to the course start date that will contain additional information. If you do not receive information, check this website for general announcements or email orncs@utmb.edu.

    Q15: Will I need to download any applications prior to attendance?

    A15: 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.

    Q16: I did not indicate during course pre-registration that I wanted to take one of the online GLP courses. I would now like to take one. What steps should I take?

    A16: 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.

    Q17: I indicated my interest in taking one of the online GLP courses. When will I have access to the course and how long will I have access?

    A17: 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.

    Q18: Will the presentation slides be made available to attendees?

    A18: Presentations will be provided after the course for sessions where faculty provided consent to release. Some information may be redacted.

    Q19: Will sessions be recorded and available for attendees?

    A19: 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.

    Q20: I am an in-person attendee and am planning to sign-in each day using the WHOVA App. Do I also need to physically sign-in each day?

    A21: Yes, please physically sign-in as you arrive each day.

  • Logistics

    Q22: Will there be parking on campus near the Health Education Center?

    A22: Yes; in-person attendees will receive parking information in a Logistics email that will be sent approximately one week prior to the start of the course.

    Q23: Will lunch be provided?

    A23: No, lunch will be on your own. There will be extended lunch breaks to allow for eating at local restaurants.

    Q24: I need to travel home on Friday. Will the course end early to allow time to travel to the airport?

    A24: Yes, the course will end around 12:30pm on Friday, April 19. 2024. This will allow ample time to commute to the airport. Please note that Houston Intercontinental Airport (IAH) is located north of Houston, and we recommend you allow extra travel time to this airport.

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

Past Courses

Non-clinical courses history

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  • Course History by Year

    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

Testimonials

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

Highlighted speakers  - Non-Clinical

Ian Crozier, MD
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Simon Funnell, PhD, FRSB
Read More
Elizabeth Higgs, MD, MIA, DTMH
Read More

Galveston Island Highlights

Images of Galveston  - Non-Clinical

The Tremont House
Galveston Beach
Historical Homes
The Historical Strand District
1877 Tall Ship Elissa
The Mardi Gras Arch
Moody Gardens
Galveston National Lab

Other Scientific Symposiumsin Galveston, TX

Need More Information?

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

Please reference "Nonclinical Course" in Email Subject Title.