Complaint Handling Violations for Device Companies Agenda

Complaint Handling Violations for Device Companies
The #1 Warning Letter
An FDAnews Virtual Conference
Thursday, March 28, 2013 • 10:00 a.m. – 4:00 p.m. EDT

10:00 a.m. – 10:15 a.m.


10:15 a.m. – 11:15 a.m.

We’re with the FDA and We’d Like to Start with Your Complaint Files — How Does the FDA Review Complaint Files?
Many devicemakers have recently mentioned that FDA investigators begin their inspections with complaint handling systems. If you cringe at the thought of the FDA poking around your complaint management systems you’re not alone. In 2012, 105 firms received warning letters and many more got Form 483s. In this session you’ll learn how and why the FDA likes to start with your complaint systems, what they typically ask to review and what red flags they are looking for. You’ll also discover best practices for managing paper versus electronic files and how a firm can better prepare its files for inspection.

Rita Hoffman, Managing Partner, Regs & Recall Strategies, LLC

11:15 a.m. – 11:30 a.m.


11:30 a.m. – 12:30 p.m.

10 Things I Learned the Hard Way Regarding Complaint Management — An In-the-Trenches, War Story Documentary of What Can Go Wrong and How to Fix It
This presentation will discuss in an open and frank manner 10 important lessons learned after years of managing complaints. If you’re new to complaint handling — or an old salt — this presentation will provide tips and tricks to keep your department off the FDA’s radar screen. Plus, in the Q&A session you can anonymously ask questions about your particular concern and get straight answers.

Matts Bell, Business Development Manager, Argos Global

12:30 p.m. – 1:30 p.m.


1:30 p.m. – 2:30 p.m.

Remediation? Now? Are You kidding? How To Tackle A Medical Device Complaint Remediation Project When You're Buried In Complaints
We’ve heard the horror stories and read the scary warning letters. But what do you actually need to do when the FDA has mandated complaint remediation while you are drowning in unprocessed complaints? Understand and learn how to handle these challenges from an industry leader who has directed large-scale remediation efforts for two Fortune 500 medical device companies. Benefit from his expertise setting up a medical device complaint handling system from the ground up. Understand how to manage global regulatory requirements that are not standardized. Hear proven methods of dramatically re-engineering your processes to make them more complaint, effective, and efficient.

Joaquin Kurz, Director, Quality Assurance, CircuLite Inc.

2:30 p.m. – 2:45 p.m.


2:45 p.m. – 3:45 p.m.

Promises and Pitfalls: The Art of Preparing and Implementing eMDR
Pop quiz: eMDR is an incredibly useful tool to help your company more effectively handle complaints…or eMDR is a technical nightmare that will tax your team and leave you vulnerable to new regulatory review? The answer is up to you. Mishandled, eMDR implementation can take too much of your organizations time and resources. But if you’ve got a smart plan in place, it can be one of your front line defenses against serious complaint system weaknesses. In this session, you’ll learn from a leading expert how to get it right, what your options are for implementing and how to benefit from eMDR.

Deborah Kacera, Regulatory and Industry Strategist, Pilgrim Software

3:45 p.m. – 4:00 p.m.

Closing Remarks