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Beginning September 7, the FDA will require devicemakers to use a new coding system and form for adverse event reporting. This most recent coding system was developed to improve, harmonize and expand the terminology and systems being used to code information relating to adverse events.
Join us on August 20 to understand the new IMDRF codes and prepare for your Medical Device Reports (MDR).
The FDA is not alone in making changes to its MDR form. The EU implemented a new mandatory MIR form this past January. EU Notified Bodies expect manufacturers to have already implemented the new form as part of the vigilance process.
Dan O’Leary, President of Ombu Enterprises, will present on what you must know and do today and before your September 7 deadline.
Webinar Takeaways:
- An introduction to the IMDRF code sets
- An explanation of the code set structures
- The planned changes to FDA’s reporting form
- The relationship between the IMDRF codes and the current FDA codes
- An explanation of the EU Manufacturer’s Incident Report (MIR)
- A description of the IMDRF codes used in the EU’s MIR
The IMDRF code deadline is near. Understand the new coding system and stay compliant. Register today.
Who Will Benefit
People involved in the inspection, measuring and test equipment (IM&TE) control program, particularly:
- Quality Managers
- Quality Engineers
- Production Managers
- Production Supervisors
- Manufacturing Engineers
- Production Engineers
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Webinar plus Recording & Transcript Bundle
Learn more
Best Value! You’ll have access to one log-in for the live 90-minute webinar for unlimited participants. You also receive all presentation materials and the opportunity to ask questions by phone and email, plus an audio recording and transcript for the entire session. Delivery is approximately two weeks after the session.
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$487
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Webinar only
Learn more
You get one log-in for the live 90-minute webinar for unlimited participants, presentation materials and the opportunity to ask questions by phone and email.
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$287
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24/7 Encore plus Recording & Transcript Bundle
Learn more
You'll have access to one log-in for an archived recording of the entire 90-minute webinar, including the Q&A period, for unlimited participants. You can log in any time of day or night. You'll also receive all presentation materials, plus an audio recording and transcript for the entire session. Delivery is approximately two weeks after the session.
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$487
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24/7 Encore Presentation
Learn more
You'll have access to one log-in for an archived recording of the entire 90-minute webinar, including the Q&A period, for unlimited participants. You can log in any time of day or night. You'll also receive all presentation materials.
|
$287
|
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Webinar Recording & Transcript Bundle
Learn more
You'll receive an audio recording and written transcript of the entire 90-minute webinar, including the Q&A period, and all presentation materials. Delivery is approximately two weeks after the session.
|
$287
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