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

Training Options

  •   Duration: 60 Minutes  
  • Recorded Access recorded version only for one participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
    Price: $295.00
  • Refund Policy

Overview:

Virtually all 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 straightforward, helpful methods for incorporating it into your company’s ongoing quality system.

Areas Covered in the Session:

  • 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
Jeff Kasoff, RAC, CQM, is the Director of Quality at Medivators, a leading manufacturer of consumables and instrumentation in the endoscopy field. Among his responsibilities is multi-facility oversight of the CAPA system. In his 20+ years of Quality and Regulatory management, Jeff has implemented and overseen document control systems at all sizes of company, from startup to $100 million in revenue. Over that time, he has also been primary liaison with FDA inspectors and notified body auditors. Jeff received his regulatory affairs certification in 1996, and his certified quality management certification in 2013.


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