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 MDR's, and how do you handle recalls? What are the current FDA enforcement trends in these areas? Industry experts and FDA staff will explore these issues during this two day workshop.
This course has been pre-approved by RAPS as eligible for up to 12 credits towards a participant’s RAC recertification upon full completion.
Agenda Topics Include:
- Complaints: Definitional questions
- Setting up a complaint system
- Handling complaints & trending
- Recalls and other field actions
- Understanding MDRs
- An introduction to Health Hazard Evaluation (HHE)
- Reporting and products liability
- Part 806 reports of removals and corrections
- Current FDA inspection and enforcement trends
- Measuring the effectiveness of your complaint system
- Michelle Rios, Office of Surveillance and Biometrics, FDA
- John Kelly, Bass Berry & Sims
- Bill Greenrose, Deloitte
- Mutahar Shamsi, Deloitte
- Sara Dyson, Assistant Vice President, Risk Management, Medmarc
- Linda Chatwin, Esq, RAC, Senior Customer Solutions Consultant, UL LLC
- Additional speakers to be announced
701 Pennsylvania Ave., N.W., Ste. 800
Washington, DC 20004
AdvaMed Member Registration: $1,595.00
Accel Member Registration: $695.00
Government and Non-Profit Registration: $695.00
Non-Member Registration: $2,095.00
Cancellation and Refund Policy
All cancellations must be received via email to AdvaMedEvents@AdvaMed.org. Cancellations received 10 business days or more prior to the start of the program are eligible for a full refund. There will be no refunds for cancellations received less than 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 us at AdvaMedEvents@AdvaMed.org 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 to change without notice. AdvaMed reserves the right to cancel or reschedule any program, and the full registration fee 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.