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How to Prepare for an FDA Inspection
Length of Course
1 Day
Deliver Method
Classroom
Materials
Each participant will receive a training manual
Certificate of Completion
A certificate of completion will be issued on successful course completion.
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.
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Participants on this course will learn the QSIT inspection technique and how to preapre for these audits.
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On completion of this training, participants will be able to:
- Understand the benefits and objectives of FDA’s QSIT
- Understand how to plan and prepare for your FDA inspection
- Understand what inspectors look for during a QSIT inspection
- Develop strategies to prepare for and manage FDA inspections
- Gain knowledge of the FDA enforcement actions
- Anyone involved with FDA inspections