Medical Device Complaint Systems Strategies for Managing Your Biggest Compliance Challenge

Held Feb. 24, 2010

What exactly does the FDA expect of device and diagnostics firms regarding complaint system reporting?

With a new rule on eMDR expected soon, you need to get up to speed now. Here’s how —without leaving your desk.

Are you ready for eMDRs? The long awaited, and hotly contested, proposed rule on eMDRs appears to be getting closer to final approval. The extended comment period ended November 16 and 2010 looks like the year we’ll see the final version. Industry estimates suggest it will cost $50 million to $80 million to comply.

But eMDR is not the only concern. Warning letters and 483s are already raining down on companies whose complaint management systems fall short of FDA standards. Did you know:

  • That all complaints under 21 CFR 820.198 and ISO 13485 are not equal? Some are serious, some not so. Do you know how to tell one from the other?
  • That the FDA can ding you for failing to train front-line employees to spot complaints? Customer service staff, sales and field agents are your eyes and ears. Have you tuned them in?
  • Under 21 CFR 806 you must keep records of all corrections and removals — even those not required to be reported. Sound easy? Then why so many warning letters on the topic?

Clearly, complaint systems are a complex, fast-changing subject, with big penalties if you get things wrong. Isn’t it worth a day of your time to straighten matters out?

Mark your calendar now for Wednesday, Feb. 24, 2010. It’s an all-day skull session featuring the latest thinking of FDA insiders ... solutions from industry colleagues who face the challenges you face ... and consultants who deal with dozens of companies like yours.

No need to pack your bags for this conference — it’s virtual. Just plan to spend the day near a computer screen. And if you’re not available the day of the conference, you can still choose the Audio CD and transcript, including Q&As and full sets of presentation materials, available four weeks later. Or dial up the 24/7 ENCORE™ Presentation for a recording of the proceedings plus all seminar materials. There’s no limit on the number of dial-in participants and the 24/7 ENCORE™ is available for three weeks – 24/7, of course.

View the
complete agenda.

Clearing Up the Confusion on MDR

Deborah Kacera, Senior Project Manager at Pilgrim Software, helps you prepare for the coming electronic Medical Device Reporting (eMDR) regulations, including best practices for complaint recording, investigations, root cause analysis, resolution and reporting. She has provided recommendations to the FDA regarding additional and adjusted content for eMDR document requirements and input into coding changes to increase eMDR submission process efficiency. Kacera has been invited to participate in the FDA’s Problem/Adverse Event Codes Working Group.

Kacera is joined by five other expert panelists who touch on every important aspect of medical device complaint systems in an information-packed day:

  • Brandi Stuart, acting Chief of the Information Analysis Branch, CDRH FDA, discusses where eMDRs are and where they are going.
  • Consultant Susan Reilly, Reilly & Associates LLC, analyzes the different definitions of “complaint” under 21 CFR 820.198 and ISO 13485.
  • Tatyana Chorny of Philips Healthcare tells how to use statistical techniques — scatter plots, check sheets, Pareto charts, cause-and-effect diagrams — to create and maintain procedures for device servicing in compliance with 21 CFR 820.200.
  • John Talarico of Delcath Systems shows how to train employees to recognize and react to complaints in ways that meet FDA requirements.
  • Edward Wilson, Partner, Hogan & Hartson, will help you cut through the confusion, explaining legal intricacies in plain English.
  • Consultant Dan O’Leary of Ombu Enterprises, shows how to live up to 21 CFR 806 reporting responsibilities — key essentials that will help you get ready for inspections and avoid mandatory recalls.

Mr. O’Leary, virtual conference chair, has 30+ years of experience in quality, operations and program management in the medical device and clinical lab industries, as well as aviation and defense. His firm, Ombu Enterprises LLC, serves small manufacturing companies with advice and counsel on operational excellence and regulatory compliance.

Worth Your Time ... and Then Some!

Want specifics? Here’s a small sampling of topics and items on the virtual conference agenda:

  • How to evaluate each complaint to determine if an MDR is required
  • 6 key elements the FDA requires in a service report and which records must be kept
  • Understanding the requirements that make statistical analysis mandatory
  • What service people should look for to identify consumer complaints
  • How to train sales personnel to recognize and report complaints
  • Terms, definitions and forms that firms are responsible for when submitting MDRs
  • Who is qualified to make medical judgments and who the FDA will deem appropriate
  • Distinguishing between a correction and a removal and defining terms such as “market withdrawal,” “routine servicing” and “stock recoveries”
  • Which documents your firm needs to keep and when reports are required for a correction or removal
  • And much more!

Order Now!

No Planes, No Trains, No Automobiles

You’d gladly (or maybe grudgingly) get on a plane and check into an unfamiliar hotel to attend a conference so timely. Good thing you don’t need to.

  • Stress-free! No airport nightmares, no hotel snafus, no waking at 4 a.m. to catch an early flight. You never leave your building. You don’t even need to leave your desk.
  • Interactive! Plenty of opportunities to ask questions and get involved. Send in queries via e-mail ... you’ll have answers before you log off.
  • Up-to-the-minute! Every speaker operates in the real world, in real time. If something important happens on conference morning, you’ll hear about it from a speaker before the sessions end.
  • Great value! Spread the word! There’s no limit on number of attendees per site. One low registration fee covers them all.