Stelex U / Experience

Experience

Stelex University was initially established in 1998 as the internal training program of Stelex, a consulting firm providing quality solutions to FDA-regulated, mission-critical environments. Stelex University has contributed to Stelex's success by keeping a constant focus on the ever-changing technological and regulatory environments and transferring this knowledge to our consultants and clients. Stelex University's staff is made up of subject matter experts who have hands-on experience in the assessment, development, validation and implementation of computer systems and the policies and procedures needed to support them. They have participated on panels with federal investigators, in training and educational seminars and have written articles for leading national publications.

Stelex University recognizes that training and knowledge transfer is a vital element of your business' compliance efforts and success. To assist industry in meeting the challenges of regulatory compliance, Stelex has developed a series of Computer System Validation (CSV) and regulatory courses based on good engineering practices and the FDA's internal training. These courses are designed to aid industry in designing, developing, verifying, validating and auditing computer systems that comply with accepted good engineering practices and FDA regulations.

Stelex University's staff has shared its expertise with some of the largest pharmaceutical, medical device and diagnostics manufacturers in the world. These subject matter experts have successfully managed the development and implementation of computer systems and the supporting quality system policies and procedures. This expertise and real world experience is carried into their training sessions. Staff qualifications include:

Seminars and Conferences

Stelex University's staff has participated in many of today's leading training and educational seminars. They have been members of panels including FDA investigators and other industry experts. In addition, they have published in many leading trade journals and other publications.