510(k) Preparation, Submission, and Clearance - Webinar By GlobalCompliancePanel by globalcompliancepane


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    RAPS Approved Webinar                  on
     510(k) Preparation, Submission, and Clearance

    Date & Time:                                                                                                                         

     Course "510(k) Preparation, Submission, and Clearance" has
     been pre-approved by RAPS as eligible for up to 1.00 credits
                                                                                                  Register Now                           

     towards a participant's RAC recertification upon full completion.

                                                                                            Instructor Profile:
     Wednesday, October 3, 2012          10:00 AM PDT | 01:00 PM EDT

     Duration: 60 Minutes                Instructor: David Lim                                              David Lim
                                                                                                        Chairman and CEO,
     Location: Online                    Price : $245.00   (for one participant)
                                                                                                         Regulatory Doctor

                                                                                            Dr. Lim obtained his Ph.D. in
                                                                                            biological sciences at the University
    This webinar is intended to demonstrate how to prepare a 510(k) in                      of Missouri-Columbia and published
    an adequate manner with increased quality for submission and                            his thesis research in the prestigious
    subsequent clearance.                                                                   journal “Science.” Since then, Dr.
                                                                                            Lim has held various positions at
                                                                                            Duke, US National Laboratories,
    The section [510(k)] of the Federal Food, Drug, and Cosmetic Act
                                                                                            Intrexon Corporation, Terumo, US
    (FD&C Act or the Act) describes the premarket notification
                                                                                            FDA/CDRH, and EraGen Biosciences,
    requirements. The premarket notification [510(k)] is the most                           Inc., A Luminex Company. In 2009,
    common pathway to market for medical devices. The 510(k)                                Dr. Lim served as a member during
    premarket submission is made to US FDA to demonstrate that the                          the FDA’s Transparency Public
    subject device (to be marketed) is substantially equivalent (as least                   Meeting. Prior to founding his own
    a s safe and effective) to a legally marketed device (predicate device)                 consulting firm
    a s described in 21 CFR 807.92(a)(3). In other words, 510(k)s must                      (www.RegulatoryDoctor.com), Dr.
                                                                                            Lim was Senior Vice President of
    demonstrate that a proposed product is substantially equivalent to
                                                                                            Scientific and Regulatory Affairs at
    another, legally marketed medical device that is also lower-risk and
                                                                                            Aquavit Pharmaceuticals, Inc. in New
    is not subject to premarket approval (PMA). Over time, the 510(k)                       York, wherein Dr. Lim provided
    program has significantly evolved, affecting the 510(k) decision-                       inspiring and actionable solutions for
    making process.                                                                         sustainable business operation. Dr.
                                                                                            Lim as Regulatory Doctor provides
                                                                                            practical, actionable and strategic
    Areas Covered in the Session:                                                           solutions integrated with emotional
                                                                                            intelligence (EQ) skills for all aspects
       l   Governing statute(s) and regulations                                             of global regulatory, quality, clinical
                                                                                            and compliance matters. Over the
       l   Definitions
                                                                                            years, Dr. Lim has analyzed over
       l   Device classification
                                                                                            1,000 FDA warning letters. ...more
       l   How to identify a suitable predicate device(s), if any.
       l   How to demonstrate substantial equivalence
       l   Recent changes in the 510(k) program.
       l   Decision points during 510(k) review                                            Suggest a Topic        More Webinars
       l   Differences in contents of 510(k)s based on products
                                                                                             Your Necessity is our Priority
       l   How to identify regulatory requirements relevant and
           applicable to the product(s).
       l   How to address the relevant and applicable regulatory
       l   How to present your performance data and clinical data in a
           succinct, comprehensive manner.
       l   How to increase 510(k) submission quality for a product.
       l   How to respond to FDA’s request of additional information.
       l   How to resolve different opinions between the submitter and
           FDA reviewer(s).

    Click here to register for this webinar

    Who Will Benefit:

       l   Regulatory Affairs Managers, Directors and VPs
       l   Clinical Affairs Managers, Directors and VPs
       l   Quality Managers, Directors and VPs
       l   Quality Managers, Directors and VPs
       l   Compliance Managers and Directors
       l   Sales and Marketing Managers, Directors, and VPs
       l   Complaint Handling and Risk Management Managers and
       l   Site Managers, Directors, and Consultants
       l   Senior and Executive Management
       l   Compliance Officers and Legal Counsel
     l   Business Development Managers, Directors, and VPs

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,

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

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