FDA’s National Center for Toxicological Research (NCTR) Selects Stelex University
Stelex University is selected to Provide SOP Writing and GLP Compliance Training
Bensalem, PA November 9, 2006 - Stelex University (Stelex U) the professional education and technical training arm of Stelex was once again selected to conduct training sessions for the FDA’s National Center for Toxicological Research (NCTR) on the topics of SOP writing for the implementation of their Master Validation Plan and GLP compliance. All of these sessions were broadcast live throughout the center and were very well attended.
The topics of the sessions included:
- Management, Facilities, and GLP Compliance – focused on the responsibilities of management in GLP studies
- How to Write an SOP: The Basics – reviewed the basic content of SOPs, the writing styles and goals
- Writing SOPs in Depth: Computer System Validation Plan SOP – practiced writing the main sections of a Validation Plan SOP in a workshop style setting
Stelex U staff is made up of subject-matter experts who have hands-on experience in the assessment, validation, development and implementation of computer systems and the policies and procedures needed to support them for some of the world’s leading healthcare companies. Instructor James Bardunias, stated, “It is always rewarding to work with the agency and to gain NCTR’s perspective on GLP Compliance.”
In a letter referencing the training conducted by Stelex U, NCTR Director, Dr. William Slikker Jr. stated “This insight is extremely important for us in the implementation of our Computer Systems Master Validation Plan and in addressing GLP-compliance issues.”
For more information about the
FDA-NCTR IT Initiatives go to NCTR's Research Program Initiatives.