Recalls & Vigilance - When to Report Complaints by davidross759

VIEWS: 40 PAGES: 2

This webinar will acquaint one with the lessons
learned from over 30 years of adverse events and complaints.
FDA has issued warning letters for failing to properly evaluate
medical device complaints for reporting under 803 & 806
regulations. Vigilance reporting is also required in Canada,
the European Union and many other countries. Warning
letters and recalls are posted on FDA's website and published
in trade magazines, newspapers available to firms'
competitors.

More Info
									                                                                                                                                       




         Date : Tuesday, June 21, 2011

         Time : 10:00 AM PDT | 01:00 PM EDT
                                                     Live Webinar
     Duration : 60 Minutes                           Recalls & Vigilance - When to Report
                                                     Complaints
        Price : $245.00


                                                          
      Overview: This webinar will acquaint one with the lessons                                                                    
      learned from over 30 years of adverse events and complaints.
                                                                                          Register Now

      FDA has issued warning letters for failing to properly evaluate             Instructor Profile:
      medical device complaints for reporting under 803 & 806
                                                                                           John Chapman
      regulations. Vigilance reporting is also required in Canada,
                                                                                           Regulatory Affairs
      the European Union and many other countries. Warning                                 Professional
      letters and recalls are posted on FDA's website and published
                                                                               John Chapman, BS, MBA, RAC has
      in trade magazines, newspapers available to firms'
                                                                               over 30 years medical device
      competitors.
                                                                               regulatory experience and over 10
                                                                               years experience with the European
      Areas Covered in the Session:
                                                                               Union's medical device directive,
                                                                               93/42/EEC. John has led two device              
        l    Complaint definitions - FDA, Canada & Europe                      companies to ISO quality system
        l    FDA's complaint handling requirements                             certification and CE marking. He has
        l    Canada & European Union complaint handling                        been performed regulatory due
        l    FDA's voluntary & mandatory reporting                             diligence on over a dozen
        l    21CFR 803, 806 & 810 explained                                    acquisitions in the past 12 years,
        l    FDA regulatory actions against firms                              exposing him to numerous quality
        l    Adverse event reporting - Canada & Europe                         systems, including consent decrees
                                                                               as well as many notified bodies.
      Click here to register for this webinar                                  ...more
                                                                                  Related Products
      Who Will Benefit:
                                                                                  ISO 13485 Gap Analysis Toolkit
        l    Design Engineers
                                                                                  ISO 13485 Quality Manual
        l    Regulatory Professionals                                                                                          
        l    Technical Writers                                                    Intro to ISO 13485 Presentation
        l    R & D Managers                                                       Materials
        l    Design Engineers                                                     ISO 13485 Internal Auditor Checklist
        l    QA Managers
                                                                                                                    more...

                                                                                     Your Necessity is our Priority
                                                                                                                           




      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


      If you do not wish to receive this training alerts from GlobalCompliancePanel Click Unsubscribe

								
To top