The Essentials of Medical Device Regulations: A Primer for Manufacturers and Suppliers

Tuesday, September 14 – Wednesday, September 15, 2010

Dallas, TX | Sheraton Dallas Hotel


This two-day program, co-sponsored with FDA’s Dallas District and the Center for Devices and Radiological Health, is designed to teach small manufacturers and those new to the industry the essentials of medical device regulation, the scope of FDA authority, premarket submissions procedures, the quality system regulations, postmarket requirements, and sources of help and information. The program also includes an overview of medical technology reimbursement and the shifting ethical and legal guidelines for the sales and marketing of medical technology. Program faculty includes key representatives from FDA’s Dallas District Office, the Division of Small Manufacturers, International, and Consumer Affairs, the CDRH Office of Compliance, and from industry. Ample time is available for general discussion and for informal conversation with FDA speakers.

Click here for the Full Agenda


Who Should Attend

Small Manufacturers of Medical Devices -Medical Technology Innovators  -New Hires in Regulatory Affairs -Suppliers and Importers Interested in Regulatory Issues

 

Registration for this course is now closed.




Agenda Overview
View Full Agenda

Organizational Structure of FDA
Doing Business in a Regulated Industry
Overview of the Quality System Regulation
Management Responsibility
Design Control
Import Operations (Medical Devices)
Purchasing Controls and Acceptance Activities
Production and Process Control
Corrective And Preventive Actions
Complaint Handling, MDR and Servicing
FDA Inspections
Compliance Issues
Training and Audits
Manufacturers and Suppliers – The Chain of Regulatory Responsibility
Interacting with FDA – Where Do You Go for Assistance?
Reimbursement and Medical Technology
Fraud and Abuse
The AdvaMed Code of Ethics

Click here for the Full Agenda


Speakers

Reynaldo (Ricky) R. Rodriquez, Jr., Dallas District Director, FDA
William M. Sutton, Deputy Director, DSMICA, FDA/CDRH
David Arvelo, Small Business Representative (SBR), FDA Southwest Region
Demetrios Kouzoukas, Of Counsel, Covington and Burling LLP
Nicole Petty, Senior Manager, Learning & Development, Stryker Instruments
Jason Cone, Senior Vice President, Chief Compliance Officer, Kinetic Concepts, Inc.
Additional speakers coming soon.

Click here for the Full Agenda

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General Information

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.

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. For information regarding registration issues, please contact Katia Kunze.

Please be advised that any registrations received after 5 pm on Wednesday June 30th 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 via email to Katia Kunze. Cancellations received 7 business days or more prior to the start of the program are eligible for a full refund. Cancellations received 3-6 days prior to the start of the program are eligible for a refund but are subject to a 10 % percent cancellation fee. There will be NO REFUNDS for cancellations received within 3 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 registration 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 Dallas Hotel
400 North Olive Street
Dallas, TX 75201
214-922-8000

A limited number of rooms have been reserved at the Sheraton Dallas Hotel, at the reduced rate of $117. Please select the hotel name above, and it will bring you directly to the reservations page, or feel free to contact the hotel at 888-627-8191 and identify yourself as a member of the Advamed FDA Primer group. Please make your reservations early as the room block may fill up before the August 23rd cut off date. Room availability and rates are subject to hotel availability after the August 23rd cutoff date.

For information regarding hotel issues, please contact Cindi Brooks.

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Frequently Asked Questions

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