eMDR Final Rule Going Live August 14, 2015 - Are you ready?

Duration: 90 Minutes
This webinar will explain about the FDA final rule on Electronic Medical Device Reporting so your company can be ready.
eMDR Final Rule
Instructor: Susanne Manz
Product ID: 500877

FDA published a final rule on Electronic Medical Device Reporting ((eMDR) on February 13, 2014,) that requires manufacturers and importers to submit MDRs to the FDA in an electronic format that the FDA can process, review, and archive. Manufacturers and importers will have until Aug. 13, 2015 to begin submitting all MDR reports electronically.

The two options for submitting eMDRs are: eSubmitter or Health Level 7 Individual Case Safety Reports (HL7 ICSR. If you are unable to meet this date, you must request and obtain an exemption from electronic reporting to continue to report via hardcopy past Aug. 13, 2015.

Why Should you Attend:
Medical Device Reporting receives much scrutiny from the FDA so it is very important to perform it correctly in a timely and efficient manner. Failures to report correctly not only result in compliance issues but can create significant risks for your customers as well.

This webinar will cover the following significant areas:
  • Changes to reporting requirements: Final Rule
  • Timing of changes
  • Requirements for submitting MDR reports electronically
  • How to prepare for the coming changes
  • Inspection Readiness
  • Best Practices
Objectives of the Presentation:
The objectives of the presentation are to:
  • Understand the changes
  • Share best practices
  • Identify actions for your company to take
  • Ensure inspection readiness
Who can Benefit:
Individuals in the following roles at Medical Device Companies:
  • Complaint Handling Units
  • Compliance and Audit professionals
  • Regulatory Affairs Professionals
  • IT Support for Complaint Handling Units
$375
Recorded Session for one participant
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  • Please share your valuable Feedback at the end of the session
Instructor Profile:
Susanne Manz is an accomplished leader in the medical device industry with emphasis on quality, compliance, and six sigma. She has an extensive background in quality and compliance for medical devices from new product development, to operations, to post-market activities. She has a BS in Biomedical Engineering and an MBA from the University of NM. She earned her Black Belt and Master Black Belt certifications while at Johnson and Johnson. Susanne also holds Regulatory Affairs Certification (RAC) from RAPS and Certified Quality Auditor (CQA) certification from the American Society for Quality. Susanne has now established a consulting business with a mission to provide services to help medical device companies achieve world-class quality and compliance.
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