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Enroll three students in the same course (held on the same date and at the same location) at the regular price and receive a fourth enrollment for free. *This offer cannot be combined with any other promotional offer(s).

FDA's Quality System Inspection Technique (QSIT)

In response to customer feedback, starting January 2012, this two day course will be combined with our one-day course, FDA's Quality System Inspectional Techniques (QSIT).

This combined three-day course, Understanding FDA's Medical Device QSR and QSIT (MDF), provides one comprehensive training session on FDA’s Medical Device Quality System Regulation (QSR) and Quality System Inspection Technique (QSIT) so you will understand how to comply with the regulations and prepare your organization for FDA inspections. Click here for more information and upcoming 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 currently no public dates scheduled. All our courses are available to be held at a location of your choice. Please contact us for more information.

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.

In-Person Full-Days: 1
CEUs: .8
VIRTUAL CLASS TIMES Close

Public virtual seminars run daily from 1:00-5:00 p.m. ET. Seminars run on Eastern Time unless otherwise noted in the Location field.

Auditor classes that require a final exam start at 11:30 a.m. on the last day to administer the final exam.

For more information download the virtual course agenda (close this window and navigate to the top of the course page) or Contact Us.

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