Recalls, Removals, and Market Corrections in Compliance with FDA and ISO Requirements by globalcompliancepane

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    Live Webinar          on

      Recalls, Removals, and Market Corrections in Compliance with FDA
      and ISO Requirements

                                                                                                                                   
     Course "Efficient Recalls, Removals, and Market Corrections in
     Compliance with FDA and ISO Requirements" has been pre-
                                                                                              Register Now                         
     approved by RAPS as eligible for up to 1.00 credits towards a
     participant's RAC recertification upon full completion.


    Date & Time:                                                                        Instructor Profile:

     Wednesday, June 27, 2012            10:00 AM PDT | 01:00 PM EDT
                                                                                                       Jeff Kasoff
     Duration: 60 Minutes                Instructor: Jeff Kasoff                                  Director of Regulatory
                                                                                                  Affairs, Life-Tech, Inc
     Location: Online                    Price : $245.00    (for one participant)

                                                                                        Jeff Kasoff, RAC, is the Director of
                                                                                        Quality at Byrne Medical, a leading
     Overview:                                                                          manufacturer of endoscopy and
    To satisfy QSR and ISO 13485 requirements, medical device                           colonoscopy devices, where he
    companies must respond to field reports swiftly and compliantly.                    oversees the operation of the quality
    There are certain circumstances in which a report from the field                    system. In this position, Jeff is
                                                                                        responsible for oversight of the
    requires the device manufacturer to take steps regarding product in
                                                                                        document control system, including
    the field.
                                                                                        maintenance of regulatory
                                                                                        documentation. Prior to this, Jeff
    It is critical that the company take the required steps in the required             spent 13 years at Life-Tech, Inc. as
    timeframes. FDA and ISO requirements overlap to a great extent, but                 the Director of Regulatory Affairs,
    not completely. This webinar sets forth the requirements for recalls,               where he was responsible for
    removals, and market corrections, and provides recommended                          compliance of the corporate quality
    practices.                                                                          system. Jeff received his regulatory
                                                                                        affairs certification in 1996. ...more

     Why should you attend:
    There are certain circumstances in which a report from the field            Suggest a Topic    More Webinars
    requires the device manufacturer to take steps regarding product in
    the field. It is critical that the company take the required steps in the     Your Necessity is our Priority
    required timeframes. If not, FDA's sanctions could be so onerous as
    to result in the company's inability to ship product.


     Areas Covered in the Session:
                                                                                                           

        l   Regulatory definitions of recalls, removals, and market
            corrections
        l   Instances which require recalls, removals, or market
            corrections
        l   What to do during recalls, removals, and market corrections
        l   Recordkeeping requirements for recalls, removals, and market
            corrections
        l   ISO 13485-specific requirements
        l   CMD-specific requirements (Canadian device regulations)


    Click here to register for this webinar


     Who Will Benefit:
    This webinar will provide valuable assistance to all regulated
    companies, since personnel training is a regulatory requirement in
    the Medical Device field. The employees who will benefit include:


        l   Regulatory Management
        l   Quality Assurance Professionals
        l   Consultants
        l   Sales/Marketing Management
        l   Senior and mid-level Management
        l   Quality System Auditors



It would be really nice if you can circulate this mail to all your deserving colleagues who can immensely
benefit from this program.

For more information, please contact the event coordinator. We look forward to seeing you at the webinar.

Best regards,
Event-coordinator
GlobalCompliancePanel



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