A pilot course entitled Achieving Data Quality and Integrity in Maximum Containment Laboratories was held April 1-5 in the Galveston National Lab. Developed as a collaborative project between UTMB and the United States Food and Drug Administration (FDA), the training program included four days of instruction plus a half day of interactive mock-BSL4 laboratory exercises in UTMB’s National Biocontainment Training Center. The primary course objective was to cross educate sponsors, scientists, veterinarians, quality assurance personnel, regulators, Agency reviewers, and Agency policy-makers to enable the conduct of regulated studies in support of product approval via FDA’s Animal Rule. For many Agency reviewers and Sponsor Contracting Officers, the laboratory exercise was a rare opportunity to experience physical restrictions due to biosafety requirements.
Sixty-nine attendees participated in the course, including FDA representatives from the Centers for Drugs, Biologics, and Veterinary Medicine, the Office of Regulatory Affairs, and the Office of Counterterrorism and Emerging Threats. Faculty and attendees included members from the Center for Disease Control and Prevention, Department of Army Inspector General Battelle, US Army Medical Research Institute of Infectious Diseases, National Institute of Allergy and Infectious Diseases and the Health Protection Agency from Public Health England, United Kingdom. The ORNcS is currently reviewing course evaluations; initial course feedback from FDA and course attendees is very positive.
The training program also included development of an online Basic GLP course. Prior to launch, course materials were reviewed by subject matter experts within the FDA.
Course funding was awarded through a collaborative educational grant with the FDA. The first year of the five-year grant required the development and implementation of the pilot training program. UTMB Course Steering Committee members governing the development and execution of the pilot training program include Dennis Trent, James LeDuc, Melissa Eitzen, Sophie Brocard, Curtis Klages, Trevor Brasel, David Beasley, Andy McNees, Je T’Aime Newton and Tasha Ri’card-Tate.