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Device Corrections and Removals - Webinar By GlobalCompliancePanel

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Device Corrections and Removals - Webinar By GlobalCompliancePanel Powered By Docstoc
					                                                                                                                                     


    RAPS Approved Webinar                 on
 
     Device Corrections and Removals

    Date & Time:                                                                                                                      

     Course "Device Corrections and Removals" has been pre-
     approved by RAPS as eligible for up to 1.5 credits towards a
                                                                                                Register Now                          

     participant's RAC recertification upon full completion.


                                                                                           Instructor Profile:
     Thursday, August 30, 2012          10:00 AM PDT | 01:00 PM EDT

     Duration: 90 Minutes               Instructor: Dan OLeary
                                                                                                         Dan OLeary
                                                                                                  President, Ombu Enterprises
     Location: Online                   Price : $245.00   (for one participant)


                                                                                           Dan is the President of Ombu
    Overview:                                                                              Enterprises, LLC, a company offering
                                                                                           training and execution in Operational
    When your firm finds a problem with one of the devices you already
                                                                                           Excellence, focused on analytic skills
    shipped, fix it for the customer. Do you report it to the FDA?
                                                                                           and a systems approach to
                                                                                           operations management. Dan has
    If you send a letter to a customer that says, "We found a problem,                     more than 30 years experience in
    but, not to worry, we will fix it for you!", you may have invoked the                  quality, operations, and program
    Corrections and Removals process. Under Part 806 of the FDA                            management in regulated industries
    regulations, you must report this event to FDA.                                        including aviation, defense, medical
                                                                                           devices, and clinical labs. He has a
                                                                                           Masters Degree in Mathematics; is
    Under certain circumstances, you may not need to report, but you
                                                                                           an ASQ certified Biomedical Auditor,
    must keep a record of your decision. You need to make sure you
                                                                                           Quality Auditor, Quality Engineer,
    know the when to report and when a record is adequate.                                 Reliability Engineer, and Six Sigma
                                                                                           Black Belt; and is certified by APICS
                                                                                           in Resource Management. ...more
    Areas Covered in the Session:


       l   The basic requirements of Part 806
                                                                                          Suggest a Topic       More Webinars
       l   When to report
                                                                                   
       l   Exemptions that you may apply
                                                                                            Your Necessity is our Priority
              ¡   Market withdrawal
              ¡   Routine servicing
              ¡   Stock recovery
              ¡   Reporting under Part 803 – Medical Device Reports
              ¡  Reporting under Part 1004 – Repurchase, Repairs, or
                                                                                                             
                 Replacement of Electronic Products
       l   The requirements of a report and the timing
       l   The requirements for records when you don’t report
       l   The expectations of a QSIT Inspection
       l   Elements of a robust system
       l   How to check your system for compliance
       l   Recalls
       l   Design changes and potential 510(k) submissions
              ¡ The current guidance

              ¡   The draft guidance


    Click here to register for this webinar


    Who Will Benefit:


       l   Quality Professionals
       l   Regulatory Professionals
       l   Risk Management Specialists
       l   Complaint Managers and Specialists
       l   Compliance Officers
       l   General/Corporate Counsel
       l   Regulatory/Legislative Affairs Professionals



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
About GlobalCompliancePanel
GlobalCompliancePanel is an online knowledge fulfillment community portal & it has put together a new model for online
compliance training by creating a single window of learning opportunities for compliance professionals & providing a
forum for expert speakers/panelists to render their services through simplified online training delivery mechanisms. Our
commitment is give compliance regulatory training, showcasing of best industry practices & quality enrichment training
sessions in a most cost effective manner. Compliance professionals can benefit from a wide range of training sessions,
giving a diverse choice of events & all sessions being either Live or recorded stream or in the form of audio CDs.
GlobalCompliancePanel portal ensures a secure & cost effective online environment and also support your E-learning
and development on/through our website. Keep track of all webinars arranged for your industry through notifications &
event calendars being mailed to your inbox. GlobalCompliancePanel opens new doors of learning opportunities for
professionals.


GlobalCompliancePanel
www.globalcompliancepanel.com
1000 N West Street Suite,
1200 Wilmington DE 19801

Phone: 800-447-9407 or
Fax your PO to: 302-288-6884


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DOCUMENT INFO
Description: Overview: When your firm finds a problem with one of the devices you already shipped, fix it for the customer. Do you report it to the FDA? If you send a letter to a customer that says, "We found a problem, but, not to worry, we will fix it for you!", you may have invoked the Corrections and Removals process. Under Part 806 of the FDA regulations, you must report this event to FDA. Under certain circumstances, you may not need to report, but you must keep a record of your decision. You need to make sure you know the when to report and when a record is adequate.