Best Practices to Assure Prompt Review, Disposition and Control Of Nonconforming Product

Jeff Kasoff

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This presentation will review the QSR and ISO requirements for document control, and provide a streamlined process for document control.

Course Objective

Document control can be a time- and paper-consuming process. Even the simplest of changes often requires an inordinate amount of time spent in the preparation, submission, distribution, and implementation of change requests, document modifications, document review meetings, document approvals, and document placement. Many companies can spend MUCH LESS time and prepare MANY LESS documents, and still be in compliance with the regulations. This presentation will review the QSR and ISO requirements for document control, and provide a streamlined process for document control. Records maintenance, distribution, and management can be similarly streamlined by this system.


Course Outline

  • QSR and ISO 13485 requirements for document control.
  • Description of typical document control system in use.
  • Streamlined document control process.
  • Paper-free document review.
  • Immediate document distribution.
  • Paper-free document management system.


Target Audience

This webinar will provide valuable assistance to all regulated companies that are interested in spending less time on document implementation. The employees who will benefit include:
  • Executive Management
  • Document Control Management
  • Document Control Clerks
  • Consultants
  • Quality system auditors

Webinar Events
Live -Coming soon!

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment


Recorded video

Recorded video session



Speaker: Jeff Kasoff,

Jeff Kasoff, RAC, is the Director of Quality at Medivators, a leading manufacturer of endoscopy consumables and instrumentation. In this position, Jeff is responsible for oversight of the quality system, including the CAPA program, and is the liaison with FDA. For the previous 13 years, Jeff served as Director of Regulatory Affairs at Life-Tech, Inc., in which capacity he was similarly responsible for quality system oversight. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Jeff received his Regulatory Affairs Certification in 1996.


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