Stelex University Provides Computer Systems Validation and Quality Auditor Training to the FDA's NCTR
News May 23, 2006
Stelex University, the professional education and technical training arm of Stelex- The Validation Group, Inc., has presented a training session entitled "Computer Systems Validation in a Good Laboratory Practice (GLP) Environment" for the FDA's NCTR group located in Jefferson, Arkansas.
The topics of the session included:
- Overview of the need for Computer Systems Validation (CSV) in a FDA- regulated environment
- Maintaining a computer system in a validated state
- The context in which CSV will be reviewed by the FDA
- The auditing of computer systems
- The concepts, terminology and methodology used in a System Life Cycle (SLC)
Stelex U has contributed to Stelex's success by keeping a constant focus on the ever-changing technological and regulatory environments and transferring this knowledge to their consultants and clients.
Instructor James Bardunias stated, "The FDA does not normally go around asking people to come and train their staff; so when they do, not only is it a rare opportunity, it is an honor."
Information Technology at NCTR encompasses the use of computers for automated data collection systems, computational science analysis, and a network infrastructure that includes servers, a high-speed LAN, and multiple T1 lines to the FDA in Maryland.
With long-lasting results in mind, the Computer Systems Validation and Quality Auditor training will help assure that studies performed by NCTR are regulatory-compliant and meet expectations related to the control of computer systems used in their studies.
In reference to the training conducted by Stelex U, NCTR Acting Director Dr. William Slikker Jr. stated, "I have already received positive feedback."
Modified Form of Botox Could Replace Opioids as Treatment for Chronic PainNews
A modified form of botulinum toxin gives long-lasting pain relief in mice without adverse effects and, in time, could replace opioid drugs as a safe and effective way of treating chronic pain, according to new research.READ MORE
Key Ingredient in Diabetes Drug Modified to Improve Side EffectsNews
Improved medications for Type 2 diabetes are one step closer thanks to a new discovery reported this week. By modifying the key ingredient in current diabetes drugs, the researchers produced a compound that was effective for hyperglycemia in animal trials, yet without the most problematic side effects of current drugs.READ MORE
Tackling Cancer at Ground Zero: Designer Molecule Inhibits Protein TargetNews
A new molecule designed by University of Adelaide researchers shows great promise for future treatment of many cancers. The new molecule successfully targets a protein that plays a major role in the growth of most cancers.READ MORE