ComplianceOnline

Document Approval, Control, and Distribution: How to Meet FDA QSR and ISO 13485 Requirements

Instructor: Jeff Kasoff
Product ID: 700254
  • Duration: 60 Min

recorded version

$229.00
1x Person - Unlimited viewing for 6 Months
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Recorded Link and Ref. material will be available in My CO Section

Training CD

$299.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days

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Read Frequently Asked Questions

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

Why Should You Attend:

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.

Areas Covered in the Webinar:

  • 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.

Who Will Benefit:

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

Instructor Profile:

Jeff Kasoff, RAC, CQM, is the Director of Quality at Medivators, a leading manufacturer of endoscopy consumables and instrumentation. In this position, Jeff is responsible for oversight of site quality system compliance, including the CAPA program, and has established and overseen document control systems. Jeff is also the liaison with FDA and notified body auditors. In his previous position, 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, and his Quality Management Certification in 2013.

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