Training and Education

Training and Education

An on-line training module on the Good Laboratory Practice (GLP) regulations (21 CFR Part 58) is included in the FDA/UTMB educational collaborative training program Achieving Data Quality and Integrity in Maximum Containment Laboratories as a course pre-requisite. This course is designed to partner with the 5-day training program and is currently only available to registrants of this course. The course includes an on-line examination and students must pass the exam before obtaining a certificate of completion. Access may be permitted under special circumstance for UTMB employees meeting the following criteria:

  • Department Chairs
  • Department Directors
  • Personnel seeking GLP refresher training

Requests should be submitted to the course instructor, Melissa Eitzen at mmeitzen@utmb.edu.

ORNcS 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 (with the exception of GLP Refresher training) 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.

Courses are:

Our courses are intended to improve the quality and integrity of research data and participants from all areas are welcome! Common participants include:

  • Principal Investigators
  • Postdoctoral Scientists
  • Research Scientists
  • Clinicians
  • Laboratory Directors
  • Research Associates
  • Veterinarians
  • Animal Care Technicians
  • Legal Counsel

Current List of Courses

Title: Laboratory Safety & Good Laboratory Practices
Course Length: 8 hours
Course No.: CTPS 6108
Credit Hours: 1
Course 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. Note: The GLP portion of this course is equivalent to the course “FDA-GLP Regulations in the Academic Setting (see description below). 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: FDA-GLP Regulations in the Academic Setting
Course Length: 8 hours
Course Overview:  This course is designed as an introductory course to the U.S. Food and Drug Administration’s Good Laboratory Practice regulations.  The course gives an overview of each section of the regulations including a discussion of the scope of the regulations, key personnel roles and responsibilities, requirements for developing standard operating procedures, and an overview of the history behind the birth of the GLP regulations--including examples of poor animal housing conditions, sloppy documentation, and fraud. Course materials include a copy of the regulations, an FDA Warning Letter, and a copy of the UTMB Institutional policy on performing GLP studies. The course also includes discussion of Quality System development and the impact of the GLP regulations on Animal Rule studies.

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.

Title: Good Laboratory Practice (GLP) Refresher Course Course
Length:
2 hours
Prerequisite: FDA-GLP Regulations in the Academic Setting
Course Overview: This course is designed to review the requirements of the GLP regulations as set forth by the Food and Drug Administration (FDA), understand GLP compliance and to be able to recognize non-GLP compliant situations. Responsibilities of personnel, the study director, sponsors, management, and the Quality Assurance Unit (QAU) will be discussed. This course is structured to be interactive, and will include plenty of opportunities for questions and discussions. Topics covered will provide practical guidance in the implementation process, documentation strategies and maintenance of a robust GLP program.

All standard courses are available upon request. If you would like to arrange training for your Department or laboratory, please send your request to ORNcS@utmb.edu. Include your name and contact information and approximate number of attendees.
Additional training is also available on the following advanced topics:

  • Performing Checksums to Verify Electronic Datasets
  • Managing the Life Cycle of Laboratory Equipment, Computer Systems and Networked Systems for Regulated Studies