Quality Systems Inspection Technique (QSIT) and How to use it to Your Advantage

Duration: 60 Minutes
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.
FDA Quality System Inspection Technique
Instructor: Jeff Kasoff
Product ID: 505266
Objectives of the Presentation
  • 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
Why Should you Attend
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.

The overwhelming majority of field inspections performed by FDA inspectors are done according to the QSIT. It is thus imperative that all regulated companies have an in-depth knowledge of this system, to enable them to prepare for the inspection. Delving into each and every section of the QSIT, this webinar also includes a helpful method for incorporating it into your company's ongoing quality system.

Areas Covered
  • History of FDA inspection methodologies, from haphazard to QSIT
  • Anticipate and prepare for FDA inspection
  • Identify what inspectors look for during a QSIT inspection
  • In depth analysis of the 4 major subsystems
  • Review of remaining subsystems
  • Knowing how to utilize the QSIT approach in internal auditing
Who will Benefit
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. This webinar provides just such an understanding. It will also benefit:
  • Top Management
  • Regulatory Management
  • Quality Management
  • Internal Auditors
  • Consultants
$375
Recorded Session for one participant
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  $500.00 Training CD
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  $600.00 Flash Drive
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Minimum 10 attendees
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Live Session - How it works
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  • The webinar joining link, username and password for joining the webinar will be updated on your OCP Account 24 hours prior to the webinar
  • Presentation handouts in Downloadable PDF format will be updated on your OCP Account 24 hours prior to the live session
  • Login to the audio conference on the scheduled date and time
  • Get answers to your queries through interactive Q&A sessions via chat at the end of the session
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account 24 hours after the completion of the session
  • Please let us know your thoughts and views at the end of the webinar, your valuable feedback will help us improve
Recorded Session - How it works
  • Login to onlinecompliancepanel with your registered username and password https://www.onlinecompliancepanel.com/login
  • Upon purchase of the recorded session a link will be updated on your OCP Account within 24 hours
  • Please click on the link to access the Recorded Session
  • Presentation handouts in downloadable PDF format will be updated on your OCP Account within 24 hours of the purchase of the product
  • Download the Certificate of Attendance and Purchase Invoice from your OCP Account after 48 hours of the product Purchase
  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Jeff Kasoff, RAC, CMQ/OE, LBB, is the Principal at Lean to Quality, LLC. He has more than 30 years in Quality and Regulatory management. Over that time, Jeff has implemented and overseen quality system operations and assured compliance, at all sizes of company, from startup to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes. Jeff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies. Jeff has the following certifications: Manager of Quality and Organizational Excellence certification from ASQ, Regulatory Affairs Certification from RAPS, and Lean Black Belt from IIE.
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