Medical Device Complaints, MDRs & Reports Workshop

April 27 – 28, 2016 — The Pew Charitable Trusts Conference Center, Washington, DC

Overview |  Agenda |  Speakers |  Logistics |  Fees

Overview

This workshop has reached capacity and registration is CLOSED. 
Please contact Annie Feutz at afeutz@advamed.org with questions.

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.

Agenda Topics Include:

• Elements of an effective complaint management system
• FDA's expectation about trending complaints from non-US markets
• How to ensure that your electronic records database handling complaints complies with 21 CFR Part 11
• How to investigate complaints to determine if they are MDR's
• The dos and don'ts when informing FDA of a product problem
• FDA's involvement in health hazard evaluation and classification
• And more...

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

Click here to Download.

Speakers

  • Bill Maloney, Physicist, MDR Policy Branch, Office of Surveillance and Biometrics, FDA/CDRH
  • Raymond Bonner, Partner, Sidley Austin
  • Kimberly Platt, RAC, Senior Principal Specialist, Regulatory and Quality Solutions (R&Q)
  • Linda Chatwin, Esq, RAC, Manager Medical Regulatory Advisory Services, North America, Life and Health, UL LLC
  • John Kelly, Member, Bass, Berry, Sims PLC
  • Nicole Schumacher, Senior Manager, Deloitte & Touche, LLP
  • Nina Premnath, Senior Consultant, Deloitte & Touche, LLP

Hotel & Meeting Logistics

Time: Wednesday, 8:30 am - Thursday 12:15 pm; Breakfasts (2), Lunch (1) & Reception Included

Location:
The Pew Charitable Trusts Conference Center
901 E Street, NW
Washington, DC 20004
202.540.6411

A hotel block has not been reserved; however, a list of local hotels is available here.

Registration Fees

AdvaMed Member Registration: $1,595.00
Accel Member Registration: $695.00
Government and Non-Profit Registration: $695.00
Non-Member Registration: $2,095.00


Please contact skinchen@advamed.org for Group Discounts.