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

Wednesday, August 12 – Thursday, August 13, 2009

San Juan, Puerto Rico | San Juan Marriott Resort


This two-day program, co-sponsored with FDA’s Center for Devices and Radiological Health and the Office of Regulatory Affairs, is designed to teach small manufacturers and those new to the industry the basics of medical device regulation and specific regulatory requirements covering device importers. The faculty includes key representatives from FDA’s San Juan District Office, the Division of Small Manufacturers, International, and Consumer Affairs, and the CDRH Office of Compliance. Ample time is available for general discussion and for informal conversation with FDA speakers.

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Who Should Attend

Medical device and diagnostics manufacturers
Medical device importers


Registration
AdvaMed Member $650 Register Now
Non-Member $650
AdvaMed EGCC Member $650
Government $650

Agenda Overview
View Full Agenda
  • Organizational Structure of FDA
  • Doing Business in a Regulated Industry
  • Import Procedures for Medical Devices
  • Compliance Operations and Medical Devices
  • Filer Audits
  • Overview of the Quality System Regulation
  • Management Responsibility
  • Design Control
  • Interacting With FDA - Where Do You Go For Assistance?
  • 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

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Speakers
Margarita Santiago, FDA
Jose Pedro, Supervisor, SJN-DO
Karl Hezel, Investigator, SJN-DO
Joseph Tartal, Branch Chief, Technical Assistance Branch, DSMICA/CDRH, Silver Spring, MD
Wanda Torres, Medical Device Specialist, SJN-DO
Noreen Muniz, Investigator, SJN-DO
Aileen Velez Cabassa, Consumer Safety Officer, DSMICA/CDRH
Nancy Rosado, Import Program Manager, SJN-DO
Rafael Nevarez, Compliance Officer, SJN-DO
Virginia Meeks, Director of Investigations Branch, San Juan, PR
Maridalia Torres, District Director, San Juan District
Judith Meritz, Partner, Baker Donelson

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General Information

Please be advised that any registrations received after 5 pm on Friday July 24th 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

San Juan Marriott Resort & Stellaris Casino
1309 Ashford Ave.
San Juan, PR 00907

A limited block of sleeping rooms have been arranged at the San Juan Marriott Resort & Stellaris Casino for attendees to this Seminar, for a reduced rate of $150 per night. 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 1-888-817-2033. Please make your reservations early as this rate is effective until July 13, 2009. Rates and room availability are subject to change after the July 13th date.

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Frequently Asked Questions

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