We offer our in-house courses online, on-site or at a location near you.
We can also customize our courses based on your specific training needs.
How to Prepare for an FDA Inspection
Level of Difficulty
Beginner (no knowledge at all of the topic).
FDA’s Quality System Inspection Technique (QSIT) program was developed to ensure thorough coverage of the Quality System Regulation (21 CFR Part 820), while also ensuring consistency of inspections.
QSIT identifies the four major subsystems of the quality system: Management Controls, Design Controls, Corrective and Preventive Actions (CAPA), and Production and Process Controls. It evaluates and describes the purpose and importance of each subsystem, providing flowcharts and inspectional objectives for each subsystem.
Participants on this course will learn the QSIT inspection technique and how to preapre for these audits.