510(k) Submissions - The Course for Beginning RA Professionals for Preparing a 510(k)

Monday, February 22 – Tuesday, February 23, 2010

Las Vegas, NV | The Westin Casuarina Hotel


This interactive workshop, taught by industry experts and key personnel from the CDRH 510(k) staff, leads participants step by step through the regulatory guidelines, practical steps, and strategic considerations for determining a product’s regulatory route to market, identifying a predicate device, planning and assembling a 510(k) submission, interacting with FDA during the review process, and dealing with post-clearance issues.

Click here for the Full Agenda


Who Should Attend
  • Compliance officers
  • Legal counsel
  • Reimbursement specialists
  • Sales & Marketing managers

    • Registration
    AdvaMed Member $1295 Register Now
    Non-Member $1915
    AdvaMed EGCC Member $1095
    Government $495

    Agenda Overview
    View Full Agenda
    The Law and Regulations
    Assembling the 510(k)
    513(g) Request for Information
    Strategy and Planning
    The FDA Review Process
    510(k) Post-Clearance Process

    Click here for the Full Agenda


    Speakers
    Heather Rosecrans, Director, 510k Staff, FDA/CDRH
    Michael Santalucia, Vice President, RA, Global Scientific Affairs, Baush & Lomb
    Connie Finch, Vice President, Regulatory Affirs, BD
    Lawrence Romanell, Office of the Center Director, FDA/CDRH
    Marjorie Shulman, Consumer Safety Officer, Pre-market Notification Staff, FDA/CDRH
    Les Weinstein, Ombudsman, FDA

    Click here for the Full Agenda

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    General Information

    It is the responsibility of the registrant to verify their company’s active membership status prior to registering.  You may check if your company is an active member by clicking here.  There will be no adjustments or refunds made for registrations made as non-members, when registrant’s company is a member company.  Higher non-member rate will be charged for registrations received under member registration when companies are found to be non-members.


    For Sponsorship Opportunities, Hotel Information and Seminar Logistics, please contact Veronica Allen.  For information regarding Registration issues, please contact Katia Kunze.

    Please be advised that any registrations received after 5 pm on Wednesday February 4th will not appear on the participants roster.  It is MTLI policy not to release revised participants rosters after the seminar.

    CANCELLATION & REFUND POLICY

    All cancellations must be received in writing by Katia Kunze. All cancellations received 11 business days or more prior to the start of the program are subject to a 10 percent cancellation fee. There will be NO REFUNDS for cancellations received within the 10 business days prior to the start of the program including "no shows".

    We welcome substitutions in lieu of cancellations at any time. Please contact Katia Kunze with the substitute's information. All cancellation refunds will be processed within 30 business days from date cancellation request is received.  Topics and speakers are subject ot change without notice.  Advamed reserves the right to cancel or reschedule any program, whereupon full registration feew will be refunded or applied to the rescheduled program in accordance with the registrant's preference.  In the event of cancelled programs, AdvaMed assumes no responsibility for transportation, hotel, or other expenses incurred by registrants.

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    Location Information

    The Westin Casurina Hotel
    160 East Flamingo Drive
    Las Vegas, NV 89109
    1-866-837-4215 (reservations)

    A limited number of rooms have been reserved at this hotel for seminar participants, at the reduced rate of $129.  Please make your reservations by contacting the hotel and identifying yourself as a member of the Advanced Medical Technology Association room block or by clicking here.  This rate will be available until February 5, 2010.  Room and rates are subject to availability after this date.  Please make your reservations early as the block will fill up quickly.

     

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    Frequently Asked Questions

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