You are here

Medical Device Complaints, MDRs & Reports Workshop

April 16, 2019 to April 17, 2019
Washington, DC
Regulatory
Workshop

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 day and a half workshop.

Click here to view the agenda

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

Hotel Block Information:
The Westin City Center
1400 M St NW, Washington, DC 20005

Room rate:  $299
Cut-off date for room reservations:  Mar. 22, 2019
Book your group rate for the workshop here

Speakers for this workshop include:

  • Jason Brooke, Navigant Consulting; Vasoptic Medical
  • Dennis Gucciardo, Hogan Lovells
  • Mike Heyl, Hogan Lovells
  • Kathryn Klaus, Risk Management Attorney, FDA Specialist, Medmarc
  • Howard Sklamberg, Akin Gump
  • Ted Wilson, Hogan Lovells

Registration Fees

AdvaMed Accel Member Registration: $695.00

AdvaMed Member Registration: $1,595.00

Non-Member Registration: $2,095.00