Regulatory Complaint Handling, MDR's & Recalls - Webinar By GlobalCompliancePanel

							                                                                                                                                


    Live Webinar         on
 
     Regulatory Complaint Handling, MDR's & Recalls

                                                                                                                                 
     Course "Regulatory Complaint Handling, MDR's & Recalls" has
     been pre-approved by RAPS as eligible for up to 1.00 credits
     towards a participant's RAC recertification upon full completion.
                                                                                            Register Now                         



    Date & Time:
                                                                                       Instructor Profile:
     Wednesday, August 01, 2012         10:00 AM PDT | 01:00 PM EDT

     Duration: 60 Minutes               Instructor: John Chapman                                    John Chapman
                                                                                                   Regulatory Affairs
     Location: Online                   Price : $245.00   (for one participant)
                                                                                                      Professional,


                                                                                       John Chapman, BS, MBA, RAC has
    Overview:
                                                                                       over 30 years medical device
    Medical device firms need to be aware of the benefits of compliance                regulatory experience and over 10
    a s well as the dangers of inadequate complaint handling. This                     years experience with the European
    Webinar will explain the regulatory process and in understandable                  Union's medical device directive,
    terms.                                                                             93/42/EEC. John has led two device
                                                                                       companies to ISO quality system
                                                                                       certification and CE marking. He has
    Many medical device firms face regulatory issues as a result of
                                                                                       been performed regulatory due
    inadequate complaint handling. FDA has explicit complaint handling                 diligence on over a dozen
    requirements and poor complaint & reporting procedures often result                acquisitions in the past 12 years,
    in costly recalls and warning letters. FDA warning letters and recalls             exposing him to numerous quality
    are posted on FDA's website and published in trade magazines,                      systems, including consent decrees
    newspapers available to firm's competitors, and has even driven the                as well as many notified bodies. He
    firm's stocks down. This presentation will review the regulations and              earned his regulatory affairs
                                                                                       certification (RAC) in 1998 and was a
    point out some of the pitfalls in complaint handling and reporting.
                                                                                       contributing author to 2004
                                                                                       Fundamentals of EU Regulatory
    Areas Covered in the Session:                                                      Affairs, RAPS, 2004. He co-founded
                                                                                       a local RAPS chapter and has been a
                                                                                       speaker at these meetings and the
       l   FDA's Complaint Definition 820.3 (b).                                       annual RAPS conference. ...more
       l   Complaint Documentation.
       l   Part 803 - Medical Device Reporting.
       l   Part 806 - Reports of Corrections & Removals.
                                                                                      Suggest a Topic       More Webinars
       l   Warning letters and other FDA Remedies.
       l   Complaint Handling Pitfalls.                                                 Your Necessity is our Priority


    Click here to register for this webinar


    Who Will Benefit:
                                                                                                         
    Some employees who wish to gain a better understanding include:


       l   Quality & Regulatory Professionals
       l   Manufacturing & Design Engineers
       l   Marketing Product Managers
       l   Corporate & Operations Executives



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
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