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Change Control Systems for Medical Devices Current Best Practices for FDA-Compliant Systems

Webinars - Change Control Systems for Medical Devices Current Best Practices for FDA-Compliant Systems
Webinars

By : Compliance Online

Date : 2011

Location : United States US / Palo Alto

Video 56m
Description :

The training will discuss the best practices to create a FDA compliant systems. Review the QSR requirements for document change control, and provide a streamlined process.

Keywords :

Compliance system, Medical devices webinar, FDA compliance

 

Why You Should Attend:
It is well known that document change control is a critical requirement for FDA-regulated companies. However, this can be a time- and paper-consuming process, in which even the simplest of changes 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. The best document change control systems are those that are fast and effective.

 

This presentation will review the QSR requirements for document change control, and provide a streamlined process - Many companies can spend MUCH LESS preparing MANY FEWER documents, and still be in compliance with the regulations; is yours one of these?

 

Who Will Benefit:

This webinar will provide valuable assistance to all regulated companies that are interested in spending less time on change control. The employees who will benefit include:

  • Executive Management
  • Document Control Management
  • Internal auditors
  • Supplier auditors
  • Consultants
  • Quality system auditors

 

Areas Covered in the Seminar:

  • QSR requirements for document change control.
  • Description of typical document change control system in use.
  • Streamlined document change control process.
  • Paper-free document review.
  • Immediate document distribution.
  • Paper-free document management system.
  • Document change requests: submission, processing, and review.
  • Document change approval and distribution.
  • How to handle "Minor" changes.
  • Streamlined document change control process.
  • Change control for design documentation.

 

Instructor Profile:


Jeff Kasoff, RAC, is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Jeff is responsible for oversight of corporate compliance with domestic and international regulations, preparation of submissions, and is primary liaison with regulatory agencies and notified bodies. 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.

 

Recorded webinar and reference materials will be available on your account after purchase.

Change Control Systems for Medical Devices Current Best Practices for FDA-Compliant Systems

Product Type : On Demand Webinar

Author : Jeff Kasoff

Video 56m

Languages : English

Organizer : Compliance Online

ComplianceOnline is a Regulatory Affairs Professionals Society(RAPS) RA Professional Development Portal provider. ComplianceOnline is committed to enhancing the ongoing professional development of regulatory affairs professionals and other stakeholders through appropriate regulatory affairs learning activities and programs ComplianceOnline has agreed to follow RAPS-established operational and educational criteria