Course Dates Upcoming Dates and Locations Virtual seminars run as 1/2-day sessions. In-person classes run as full-day sessions. See the virtual session daily class times. There are no public training classes scheduled right now but this class can be delivered privately to 6 or more people at any time. Ask us for details!
Course Details Objectives Understand the purpose, benefits and objectives of FDA's QSIT. Plan and prepare for your FDA inspection. Understand FDA's statutory authority. Manage your inspection process. Follow up after your inspection. Understand FDA enforcement actions. Topics Introduction to FDA's QSIT Statutory authority and the scope of FDA inspectional powers QSIT approach to inspections Major subsystems: management controls, design controls, production and process controls, corrective and preventive actions FDA 483s Who Should Attend Recommended for compliance, legal, management, quality, regulatory, and technical personnel who directly interface with FDA during inspections. Also valuable for anyone who needs to become familiar with FDA Quality System Inspection Technique (QSIT), especially those involved with management controls, design controls, corrective and preventive actions, and production and process controls. Virtual Half-Days In-Person Full-Days CEUs .8