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Recorded Webinar
FDA Quality Systems Inspection Technique (QSIT) and How to use it to Your Advantage
timelapse 60 Min with 15 Min QnA of Q and A
Note:
This webinar occured in the past
Along with recorded webinar, copy of presentation slides will be shared
Recorded Webinar can be played unlimited times
Speaker/Presenter
Short Abstract
Can your organization survive a Food and Drug Administration (FDA) inspection? Are you aware of the different aspects of your business that the FDA will be inspecting? This course, “FDA’s Quality System Inspection Technique (QSIT),” is intended to facilitate manufacturer compliance with the FDA’s Quality System Regulation (QSR) and related regulations, and increase inspection consistency, product quality, and the efficiency of the enforcement action review process.
This Webinar provides valuable assistance to all individuals who liaison with the FDA during inspections. It will also benefit senior management, who need to understand the methodologies used by FDA during inspections. During FDA inspections, several individuals from the organization work closely with FDA officials. For them and for senior management, understanding the intricacies of the methodologies used by the FDA is clearly of high importance.
The presentation will cover the following areas:
- Understanding the purpose, benefits and objectives of FDA’s QSIT
- How to Plan and prepare for your FDA inspection
- Identifying what inspectors look for during a QSIT inspection
- Understanding FDA’s statutory authority
- In depth analysis of the 4 major subsystems
- Reviewing of remaining subsystems
- Managing inspection process
- Following up after an inspection
- Understanding FDA enforcement actions
- Knowing how to utilize the QSIT approach in internal auditing
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