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:
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.
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:
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:
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.
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