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

Course Format

In-person (at Bluemont Hotel/ NBAF)

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.

2025 Planned Course TopicsDays and Titles are Subject to Change

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.

Course Location