Complaints, MDRs, Reports of Removals & Corrections, and Recalls

Thursday, October 22 – Friday, October 23, 2009

Chicago, IL | Sheraton Gateway Suites O'Hare


SPECIAL PROMOTION - Please do not submit your registration online, we will do it for you!

AdvaMed's MTLI is offering a $250 discount on all remaining 2009 courses. In order to obtain the $250 discount, please visit our website at www.advamedmtli.org and complete the registration form but do no submit it online.

After completing your registration form, PDF the form and email it to kkunze@advamed.org or print it out and fax it to 202.783.8750 Attention: Katia. Please indicate your request for the $250 discount in the body of the email or the fax cover sheet and we'll take it from there. Some restrictions may apply.

How do you implement and measure the effectiveness of a complaint handling system covering a diverse set of possible products and problems? How are complaint files managed across multiple domestic and international facilities? When do complaints rise to the level of MDRs, and how do you handle recalls? What are the current FDA enforcement trends in these areas? Through didactic sessions, interactive exercises, and discussion of pre-submitted questions, expert industry faculty and FDA speakers explore these issues in practical terms.

Click here for the Full Agenda


Who Should Attend

Those involved in, Complaint handling - Adverse event reporting - Health hazard evaluation - Recalls - Product safety issues


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

Agenda Overview
View Full Agenda
  • Complaints - Definitional Questions
  • Setting Up a Complaint System
  • Handling Complaints and Trending
  • Current FDA Inspection & Enforcement Trends
  • Measuring the Effectiveness of Your Complaints System
  • Understanding MDRs
  • Part 806 Reports of Removals and Corrections 
  • eMDRs
  • An Introduction to Health Hazard Evaluation (HHE)
  • Recalls and Other Field Actions
  • Postmarket Information and CAPA
  • Exercise - Managing Product Problems
  • Faculty Panel Discussion - Pre-submitted Questions

    • Click here for the Full Agenda


    Speakers
    Ted Wilson, Partner, Hogan & Hartson
    Sue Jacobs, Principal Consultant, QMS Consulting, Inc.
    Richard Roy, Technical Services Manager, AGA Medical Corporation
    Deb Kacera, Senior Product Manager, Regulatory Products, Pilgrim Software
    Paul Carlson, Program Manager, CAPA Certification, Abbott Laboratories
    Lorelei Jarrell, Pre-Approval Manager, Compliance Officer, FDA/Chicago District

    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 Thursday October 8th 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

    Sheraton Gateway Suites O'Hare
    6501 N. Mannheim Road
    Rosemont, IL 60018
    847.699.6300

    A limited number of rooms have been set aside for attendees to the Complaints seminar, at the discounted rate of $125. To make reservations, please select the hotel name above and make your reservations directly into the room block. Or contact the hotel at 847.699.6300 and identifying yourself as a member of the Advanced Medical Technology Association room block. This rate will be available until Saturday, September 26. 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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