The four and one-half day training program is offered annually utilizing expert faculty from the Food and Drug Administration, academia, and business and industry. The course includes laboratory activities conducted in mock Biosafety Level (BSL) 2 and
BSL-4 training laboratories to emphasize the differences between biosafety levels and the complexity of conducting laboratory activities in a BSL4 laboratory environment.
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:
- GLP Basic Training — This twelve (12) self-paced module on-line 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 — This self-paced on-line course is designed to refresh knowledge for attendees previously familiar with the GLP regulations.
Credits awarded: This course is submitted for Continuing Education credits for physicians, nurses, veterinarians, and quality assurance professionals. Details will be posted closer to course dates.
Target Audience: Scientists, Principal Investigators, Veterinarians, Pathologists, Sponsors, Quality Assurance Personnel, Physicians, Research Nurses, Regulators, Agency Reviewers, and Policy-makers.
Course Fees: There is no cost to attend, but seating is limited, and pre-registration is required. Note that course attendees are invited based upon diversity of roles, responsibilities, and organization. Interested participants will
be placed on a waitlist once seats are filled.
Location: Bethesda Hotel, Bethesda MD
Overall 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.
Overall 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.