Medical Device Complaint Systems Agenda

10:00 a.m. – 10:15a.m.	Introduction to the Virtual Conference
10:15 a.m. – 11:00 a.m.	Servicing Can Lead to Complaints — an In-Depth Look at 21 CFR 820.200 The FDA cites the quality system regulations 21 CFR 820.200 in warning letters that connect service reports to what it considers an unreported complaint. The regulation says that each manufacturer must create and maintain procedures for each time they service a device. This presentation will review statistical techniques that can be used to analyze service reports. Some of these techniques include: scatter plots, check sheets, Pareto charts, and cause-and-effect diagrams. Attendees will: Learn how individual service reports can lead to complaints and MDRs Understand the requirement for statistical analysis — learn how it can be used to uncover potential complaints Learn 6 key elements that the FDA requires in a service report and what records must be kept Tatyana Chorny, Customer Complaint Investigator, CT Quality & Regulatory, Philips Healthcare
11:00 a.m. – 11:15 a.m.	Morning Break
11:15 a.m. – 12:00 p.m.	Two Sides of the Same Coin: Analyzing the Definition of a Complaint in 21 CFR 820.198 and ISO 13485 According to the FDA, a complaint is any written, electronic or oral communication that alleges deficiencies related to the identity, quality, durability, reliability, safety, effectiveness or performance of a device after it is released for distribution. The International Organization for Standardization (ISO) definition of a complaint in its quality management systems standard — ISO 13485 — is essentially the same, but it lacks a requirement for effectiveness. This presentation will review the definition of a complaint and describe what an effective system Attendees will: Learn how to evaluate a complaint to determine if an MDR is required Determine if an investigation is necessary — What are the requirements for designated units and designated investigators? Discuss which records must be kept and how are they linked to MDRs Susan Reilly, Owner and Principal Consultant, Reilly & Associates, LLC
12:00 p.m. – 12:45 p.m.	EMDR Update: The FDA’s Current Thinking on eMDRs The FDA has been encouraging the use of eMDRs in recent years and is moving toward making eMDRs the rule and not the exception. The proposed rule, published in August, would require all device manufacturers to submit medical device reports (MDRs) electronically. During this session, Brandi Stuart, acting Chief of the Information Analysis Branch, will discuss where eMDRs are and where they are going. Brandi Stuart, acting Chief of the Information Analysis Branch, CDRH FDA
12:45 p.m. – 1:45 p.m.	Lunch Break
1:45 p.m. – 2:30 p.m.	Front Line Employees — Recognizing Customer Interactions as Complaints The FDA expects firms to train their employees to know what a complaint looks like and how they need to react. In two recent warning letters, the FDA cited a company for their failure to train their front line employees. This presentation will define steps companies should take to make sure their sales and service people recognize a potential MDR event and report it correctly. Attendees will: Learn how to train the sales force to recognize and report complaints Establish guidelines for customer service representatives to be able to handle complaints What service people should be looking for to identify complaints when they interact with consumers John Talarico, Sr. VP Quality Systems and Regulatory Affairs, Delcath Systems
2:30 p.m. – 3:15 p.m.	5-day or 30-day Report? Understanding MDR Under 21 CFR 803 The FDA has laid out guidelines device firms must follow in 21 CFR Part 803 that detail steps to take when filing a medical device report. Companies have many responsibilities that involve the patient, the user facilities, and their importers. Not only are you required to file medical device reports, but you must also submit any follow-up information on each. This presentation will detail all requirements that must be fulfilled, records that must be maintained, when each step must be taken and who is qualified to be involved in the process. Attendees will learn: What key terms, definitions and forms companies are responsible for Learn what the difference between 5-day reports and 30-day reports as well as which one to use and when Who is qualified to make medical judgments under 21 CFR 803.20(c)(2) Edward Wilson, Partner, Hogan & Hartson
3:15 p.m. – 3:30 p.m.	Afternoon Break
3:30 p.m. – 4:15 p.m.	CDRH’s Proposed Rule On eMDRs to Be Made Mandatory, Are You Ready? The FDA is urging device manufacturers to voluntarily adopt the agencys electronic medical device reporting (eMDR) process in anticipation of the final guidance. The Comments for the draft rule mandating electronic reporting has recently closed. Attendees will: Discover best practices for setting up a streamlined closed-loop process for complaint recording, investigations, root cause analysis, resolution and reporting Analyze the proposed eMDR rule and its impact on manufacturers Understand the implementation strategies for low and high-volume eMDR submissions — including tips for submissions to the EMEA, Canada, Japan and Australia Deborah Kacera, Senior Product Manager, Pilgrim Software
4:15 p.m. – 5:00 p.m.	Managing Corrections and Removals – Living Up To 21 CFR 806 During a standard FDA inspection of a manufacturing plant, the auditor will likely ask whether a recall or field correction and removal has been initiated and, if so, to review the related files. The FDA will then assess whether the manufacturer fulfilled its reporting responsibilities under 21 CFR Part 806. This presentation will identify key essentials companies need to be concerned with to avoid a mandatory recall and be ready for an inspection. Attendees will learn: How to distinguish between a correction and a removal and define terms such as “market withdrawal,” “routine servicing,” and “stock recoveries” When a report is required for a correction or removal as well as what documents a company needs to keep if it files a report When to report the same event as an MDR and a correction or removal Dan O'Leary, President, Ombu Enterprises

How does this virtual conference work?

The Medical Device Complaint Systems Virtual Conference takes all the best elements of the best live conference you’ve attended and avoids all the negatives. It delivers valuable clinical trial development intelligence using the internet for visual components and your speakerphone for the accompanying audio.

All you do is go to the specified website on the day of the event and dial the specified toll-free telephone number, both provided in your registration confirmation. That’s all there is to attending.

Then, relax at your desk or in your conference room, enjoying summit sessions featuring PowerPoint slide presentations, helpful handouts and Q&A opportunities where specific attendee questions will find direct answers from leading supply chain professionals.

What are the top benefits of a virtual conference?

Highly effective communication: This event uses internet and audioconferencing to create a seamless interface and deliver vital compliance and management advice using technology found in every workplace.

Great value: Select as many of your colleagues to attend as you wish and educate everyone for one low price, with no travel, lodging or per diem expenses.

Stress-free: No hotel or airport nightmares because you never have to leave your building. You’ll feel like you’re off-site at a top-flight conference, until you realize how easy it is to get things done during breaks.

Efficient: You can assign your staff to different sessions. Staffers can go to the sessions that most pertain to their responsibilities.

Content-rich: This virtual conference addresses your most challenging, complex and frustrating supplier quality problems.

Interactive: No one-way street, you’ll have plenty of opportunities to ask questions and get involved.

Up to the minute: This program will be up to the minute with the latest changes initiated by the FDA and international regulatory bodies incorporated into the event.

Comprehensive: You’ll hear from six industry experts all in the course of one day.