ORNcS Regulatory Operations Team offers free training classes
to UTMB employees. All classes are designed to educate a wide range of
students with varied education and levels of experience. Courses are
designed for individuals with little
to no experience in the development of Quality Systems and/or
conduct of regulated studies. A certificate of attendance is awarded for
successful course completion.
Title: Laboratory Safety & Good Laboratory Practices
Course Length: 8 hours
Course No.: CTPS 6108
Credit Hours: 1
Course generally offered
Spring and Fall semester
Course Overview: This course is designed to prepare postdoctoral scholars and advanced graduate students with basic tools and information about biomedical laboratory safety and
the FDA’s Good Laboratory Practices (GLP) regulations, codified under Title 21 Part 58 of the Code of Federal Regulations. It is combined with an on-line Laboratory Safety education module. Successful completion results in 1 credit to students
enrolled in UTMB's Graduate School of Biomedical Sciences Postdoctoral Scientists Certificate Program.
Title: Good Documentation Practices
Course Length: 1 hour
Course Overview: If you didn’t document it, you didn't do it! Good Documentation Practices are essential
tools in working in a regulated and non-regulated research environment. The expectations and your defined quality system will be largely the same regardless of the regulatory environment you face. This course is structured to be interactive and will
include plenty of opportunities for questions and discussions. Topics to be covered include the importance of good documentation practices, how to correct errors and omissions in data entry, how to sign, date and label data and records, how to complete
documentation such as data collection forms and how to attach raw data to forms and lab notebooks.
Title: The Importance of Writing Effective Standard Operating Procedures
Course Length: 1 hour
Course Overview: Standard Operating Procedures (SOPs) are essential tools
for the clinical and research industries. SOPs outline responsibilities, guidelines, implementation procedures, approaches, and ensure consistency within an organization. This course provides an interactive and comprehensive introduction to designing,
writing, implementing, revising, and updating of SOPs.
Education—Gulf Coast Consortia
The Gulf Coast Consortia is a collaboration of basic and translational scientists, researchers, clinicians, and students in the quantitative biomedical sciences who help advance the region’s scientific progress through participation in joint training
and research programs. Training includes Rigor and Reproducibility training and other scientific workshops to promote scientific rigor and reproducibility of published findings. For more information, visit https://www.gulfcoastconsortia.org/.
The FDA Center for Drug Evaluation and Research offers online continuing education courses through their CDERLearn Program. According to their website, “CDERLearn in the Center for Drug Evaluation and Research (CDER) offers a variety of learning
opportunities for healthcare professionals, industry, consumers, and academia. The goal is to create a body of educational and information modules about human drug regulation and activities. CDERLearn is a way to share FDA expertise in specific subject
areas to further instruct the public about the many ways CDER protects and promotes public health.”
For more information, visit https://www.fda.gov/training-and-continuing-education/cderlearn-training-and-education
Education—HHS ORI Educational Resources
The U.S. Department of Health and Human Services Office of Research Integrity offers educational resources, to include videos and case studies, addressing responsible conduct in research. Below are two examples; more information can be found via https://ori.hhs.gov/.
More references and resources available upon request at email@example.com.