How to submit a 510(k) and get it cleared from FDA

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     How to submit a 510(k) and get it cleared from FDA

                                                                                                                                        
     Course "How to submit a 510(k) and get it cleared from FDA"
     has been pre-approved by RAPS as eligible for up to 1.00
                                                                                                 Register Now                           
     credits towards a participant's RAC recertification upon full
     completion.


    Date & Time:                                                                           Instructor Profile:

     Thursday, June 28, 2012            10:00 AM PDT | 01:00 PM EDT
                                                                                                           David Lim
     Duration: 60 Minutes               Instructor: David Lim                                          Chairman and CEO,
                                                                                                        Regulatory Doctor
     Location: Online                   Price : $245.00   (for one participant)

                                                                                           Dr. Lim obtained his Ph.D. in
                                                                                           biological sciences at the University
    Overview:                                                                              of Missouri-Columbia and published
    This webinar is intended to demonstrate how submit a 510(k) and                        his thesis research in the prestigious
    get it successfully cleared from the FDA.                                              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
    To expedite the process of bringing a product to market through the                    practical, actionable and strategic
    510(k) program, it is imperative the medical device makers                             solutions integrated with emotional
                                                                                           intelligence (EQ) skills for all aspects
    understand the recent changes and be able to submit a 510(k) to
                                                                                           of global regulatory, quality, clinical
    successfully clear it.
                                                                                           and compliance matters. Over the
                                                                                           years, Dr. Lim has analyzed over
    You will leave empowered at the end of the webinar in a way that                       1,000 FDA warning letters. Dr. Lim
    you would submit your 510(k) using CAC-SI method, leading to your                      has also attended more than 50 FDA
    successful clearance of your 510(k).                                                   Advisory Panel Meetings and
                                                                                           analyzed the subject matters and
                                                                                           decision-making processes in detail.
    Why should you attend:                                                                 Dr. Lim is familiar with more than
    Successful prosecution of your 510(k) submission can save millions of                  200 medical products (medical
    dollars for your businesses. This webinar will discuss various                         devices including IVD products,
                                                                                           biologics, drugs and combination
    circumstances, each of which will help you to prosecute your 510(k)s
                                                                                           products). Dr. Lim is a certified
    better before the FDA.
                                                                                           professional for regulatory affairs
                                                                                           (RAC) and also is a certified quality
    Areas Covered in the Session:                                                          auditor (CQA) by the American
                                                                                           Society for Quality (ASQ). Dr. Lim is
                                                                                           an auditor, regulatory coach,
       l   Applicable Statute(s) and regulations for 510(k)s                               consultant and instructor for global
       l   How to identify a predicate device(s), if any.                                  matters pertaining to regulatory
       l   How to demonstrate substantial equivalence                                      affairs and compliance, quality and
       l   Recent changes in the 510(k) program.                                           clinical affairs. ...more

       l   Decision points during 510(k) review
       l   Differences in contents of 510(k)s based on products
       l   How to identify regulatory requirements relevant and                           Suggest a Topic        More Webinars
           applicable to the product(s).
       l   How to address the relevant and applicable regulatory                            Your Necessity is our Priority
           requirements.
       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.
                                                                                                              
    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
         Directors
     l   Site Managers, Directors, and Consultants
     l   Senior and Executive Management
     l   Compliance Officers and Legal Counsel
     l   Business Development Managers, Directors, and VPs



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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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Description: This webinar is intended to demonstrate how submit a 510(k) and get it successfully cleared from the FDA.