One of our most
popular training services is a combined course on 21 CFR Part 11 and the
auditing of computerized systems. As noted above, EduQuest
hired by FDA to train the agency’s field investigators, analysts, and
compliance officers on the inspection of computerized systems. Our
staff, therefore, both developed and presented this important training
material to key FDA personnel. We now offer this same training
course to the industry, and are uniquely qualified to explain to
regulated companies exactly what FDA investigators have been trained to
look for in auditing computerized systems and the use of electronic
records and electronic signatures.
also have provided detailed inspectional preparedness training, which
focuses on the scope of FDA’s inspectional authority, the approach of FDA
investigators, and how to effectively manage an inspection and respond to
investigators’ questions and document requests. In addition, we
have conducted targeted senior management briefings on such subjects as
GMP compliance, 21 CFR Part 11 and computerized systems validation,
inspectional preparedness, and recent trends in regulatory enforcement.
All of our training programs
are structured to encourage questions and audience participation, and
each student is provided a comprehensive training manual, including
copies of all presentation slides and pertinent reference material.