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The 510(k) Submission: Requirements, Contents, and Options - Webinar by GlobalCompliancePanel

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The 510(k) Submission: Requirements, Contents, and Options - Webinar by GlobalCompliancePanel Powered By Docstoc
					                                                                                                                                             


                      Wednesday, December 08,
            Date : 
                      2010
            Time : 10:00 AM PST | 01:00 PM EST
                                                        Live Webinar
        Duration : 60 Minutes                           The 510(k) Submission: Requirements,
                                                        Contents, and Options
           Price : $245.00


                                                                    
         Overview: This presentation will provide an understanding of
                                                                                             Register Now                                
         how to get a device requiring a 510(k) submission to market
         quickly. Knowing when and how to properly submit a 510(k)
         for a device or change to a device is critical to a company's               Instructor Profile:
         regulatory and financial health. Your goal is to get the 510(k)
                                                                                              Jeff Kasoff
         through the review process as quickly as possible. This
                                                                                              Director of Regulatory Affairs,
         presentation will also distinguish between the standard,                             Life-Tech, Inc
         special and abbreviated 510(k)s, and explain when each is
                                                                                     Jeff Kasoff, RAC, is the Director of
         appropriate.
                                                                                     Regulatory Affairs at Life-Tech, Inc., a
                                                                                     leading manufacturer of
         This course will describe the submission process and the
                                                                                     consumables and instrumentation in
         contents required by the FDA for a successful submission. It
                                                                                     the urodynamic and pain
         will also provide an understanding of the common pitfalls,
                                                                                     management fields. Jeff is
         delays, and possible preventive measures. Also described will
                                                                                     responsible for oversight of
         be the type of activities a company can pursue while waiting
                                                                                     corporate compliance with domestic
         for submission clearance.
                                                                                     and international regulations,                  
                                                                                     preparation of submissions, and is
         Areas Covered in the Session:                                               primary liaison with regulatory
                                                                                     agencies and notified bodies. Jeff
           l    When to submit a 510(k) for a new or modified product                has presented dozens of webinars in
           l    Types of 510(k) submissions and when to use each                     many areas dealing with regulatory
           l    What is the submission process                                       compliance. Jeff began his regulatory
           l    What is contained in a 510(k) submission package                     career as the first full-time employee
           l    How to know whether clinical data is required                        of Optex Biomedical, a device start-
           l    How is the submission package assembled                              up, where he initiated their
           l    User fees and 510(k) submissions                                     regulatory policies and procedures
           l    How to interact with the FDA and the reviewer                        and prepared their submissions. Jeff
                                                                                     received his Regulatory Affairs
         Click here to register for this webinar                                     Certification in 1996. ...more
                                                                                                                                 
         Who Will Benefit:                                                           Suggest a Topic       More Webinars

           l    Executive Management                                                    Your Necessity is our Priority
           l    Regulatory Management
           l    Professionals involved with premarket notification to                                                            
                the FDA
           l    R&D personnel involved in approving the design of
                medical devices
           l    Sales personnel involved in approving the marketing of
                medical devices

         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: This presentation will provide an understanding of how to get a device requiring a 510(k) submission to market quickly. Knowing when and how to properly submit a 510(k) for a device or change to a device is critical to a company's regulatory and financial health. Your goal is to get the 510(k) through the review process as quickly as possible. This presentation will also distinguish between the standard, special and abbreviated 510(k)s, and explain when each is appropriate. This course will describe the submission process and the contents required by the FDA for a successful submission. It will also provide an understanding of the common pitfalls, delays, and possible preventive measures. Also described will be the type of activities a company can pursue while waiting for submission clearance. Areas Covered in the Session: * When to submit a 510(k) for a new or modified product * Types of 510(k) submissions and when to use each * What is the submission process * What is contained in a 510(k) submission package * How to know whether clinical data is required * How is the submission package assembled * User fees and 510(k) submissions * How to interact with the FDA and the reviewer Click here to register for this webinar Who Will Benefit: * Executive Management * Regulatory Management * Professionals involved with premarket notification to the FDA * R&D personnel involved in approving the design of medical devices * Sales personnel involved in approving the marketing of medical devices