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Complaints, MDRs & Recalls Workshop
Led by industry and FDA experts, this workshop will provide an in-depth overview of how organizations can best tackle complaints, MDRs and recalls. Together with industry and FDA experts, we've developed a program designed to provide you with insights and strategies that you can immediately implement at your organization.
Workshop topics will 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
- Recall procedures
- Communicating with FDA - before, during and after a recall
- Crisis management
- Creating a recall strategy
Feb 11, 2020 |
|
8:30 – 9:00 am |
Registration and Continental Breakfast |
9:00 – 9:05 am |
Welcome and Introductions |
9:05 – 10:00 am |
Defining Complaints
|
10:00 – 10:45 am
|
Elements of an Effective Complaint Management System
|
10:45 – 11:00 am |
Break |
11:00 – 12:00 pm |
Handling Complaints & Trending
|
12:00 – 1:00 pm |
Lunch |
1:00 – 2:00 pm |
Understanding MDRs
|
2:00 – 2:45 pm |
An Introduction to Health Hazard Evaluation (HHE)
|
2:45 – 3:00 pm |
Break |
3:00 – 3:30 pm |
Reporting and Products Liability
|
3:30 – 4:15 pm |
Current FDA Inspection & Enforcement Trends
|
4:15 – 5:15 pm |
Measuring the Effectiveness of Your Complaint System
|
5:15 – 6:15 pm |
Networking Reception |
Feb 12, 2020 |
|
8:30 – 9:00 am |
Continental Breakfast |
9:00 – 9:45 am |
Recalls: Definitions, Practices, and Current FDA Perspective
|
9:45 – 10:45 am |
Part 806 Reports of Removals and Corrections
|
10:45 – 11:00 am |
Break |
11:00 – 12:00 pm |
Recall Procedures
|
12:00 – 1:00 pm |
Networking Lunch |
1:00 – 2:00 pm |
Mobilizing and Deploying a Field-Based Team During a Recall
|
2:00 – 3:00 pm |
Communicating with Your Team and FDA Before, During and After a Recall
|
3:00 – 3:15 pm |
Networking Break |
3:15 – 4:15 pm |
Regulatory and Business Considerations When Developing a Recall Strategy
|
4:15 – 4:45 pm |
Case Study: Lifecycle of a Recall |
4:45 pm |
Meeting Adjournment |
Speakers include:
- Mike Heyl, Hogan Lovells
- Ted Wilson, Hogan Lovells
- Youssef Halas, GE Healthcare
- Steven Niedelman, King & Spalding
- Allison Fulton, Sheppard Mullin
- Kathryn Klaus, Medmarc
- Neil Mafnas, FDA
- Allison Fulton, Sheppard Mullin
- Maureen Bernier, FDA
- Tony Blank, Infinity Biomedical Group
- Dorothy Henckel, Navigant
- Ginger Glaser, Monteris Medical
The Complaints, MDRs & Recalls Workshop will take place February 11-12 at the AdvaMed Office in Washington, DC.
Address:
701 Pennsylvania Ave. N.W.
Suite 800
Washington, D.C.
Registration Fees
AdvaMed Member Registration: $1395.00
Accel Member Registration: $695.00
Government and Non-Profit Registration: $695.00
Non-Member Registration: $1,895.00
Note: Early-bird pricing is available for AdvaMed Members and Non-Members. Register by January 25, 2020 for $200 off your registration!