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.
Who should attend? Past attendees had titles including:
- Senior Project Engineer
- Regulatory Affairs Specialist
- Manager, Post Market Surveillance
- Quality Assurance Engineer
- Complaints Specialist
- Manager, Product Safety
- Adverse Event Reporting Specialist
- Consumer Safety Officer
Who else is going? Connect with professionals from industry-leading companies that include:
- K2M, Inc
- Baxter Healthcare Corporation
- Bioventus LLC
- Roche Diagnostics Operations, Inc.
- Edwards Lifesciences
- Artegraft, Inc.
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
- Walt Murray, Principal Consultant for Pinpoint Consulting, and Strategic Partner of MasterControl
- Hillary Medina, Director of Recalls, Novasyte
- Allison Fulton, Partner, Sidley Austin
- Courtney Stevens Young, Senior Attorney, Risk Management, Medmarc
- John Kelly, Bass Berry & Sims PLC
- Mike Heyl, Hogan Lovells
- Ted Wilson, Hogan Lovells
- Dennis Gucciardo, Hogan Lovells
- FDA experts
- and more!
801 Pennsylvania Ave NW | Conference Center
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 (link sends e-mail). 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 (link sends e-mail) 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.