Training

 

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 was 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. 

 

We 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.

 

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