Complaints, MDRs, Reports of Removals & Corrections and Recalls
Tuesday, January 20 – Wednesday, January 21, 2009
Orlando, FL | The Regal Sun Resort
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.
Please submit any questions you are interested in having answered at the seminar to Bernadette Jones
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Who Should Attend
Registration
| 1 Event | 2 Events * | ||
| AdvaMed Member | $1295 | $2290 | Register Now |
| Non-Member | $1915 | $3530 | |
| AdvaMed EGCC Member | $1095 | $1990 | |
| Government | $595 | $1090 |
Agenda Overview
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Speakers
Michael Heyl, Associate, Hogan & Hartson"
Sue Jacobs, Principal Consultant, QMS Consulting, Inc.
Charles Goldberg, Director, Quality Assurance, Cordis Corp. (a J&J Company)
Deb Kacera, Senior Product Manager, Regulatory Products, Pilgrim Software
Gaurang Patel, MD, Medical Director, Complaint Handling and Safety Surveillance, Cordis Corp. (a J&J Company)
FDA Speakers TBA
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General Information
We are offering an additional ten percent discount if you register for the Enhancing Safety Risk Management, Risk Based Strategies or the Validation of Non-Product Software seminars in addition to this one. In order to receive the discount registrations for Dangerous Documents must be faxed to Katia Kunze at 202-783-8750.
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 visiting http://www.advamed.org/MemberPortal/Membership/member_company_listing.htm. 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.
To receive discounts for registering 3 or more please fax your registration to the attention of Katia Kunze at 202-783-8750. Discounts will not be given retroactively.
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 January 7th will not appear on the participants roster. It is MTLI policy not to release revised participants rosters after the seminar.
CANCELLATION & REFUND POLICY
Location Information
The Regal Sun Resort1850 Hotel Plaza Blvd
Lake Buena Vista, FL 32830
407-827-6529
A limited block of sleeping rooms have been arranged at the Regal Sun Resort for attendees to these Seminars, for a reduced rate of $139/lake view or $159/tower/city view. In order to receive the discounted rate, you must ask for the Advance Medical Technology Association room block. To make toll free reservations please contact 1-800-624-4109. Please make your reservations early as this rate is effective until January 9, 2009. Rates and room availability are subject to change after the January 9th date.