Be Ready for eMDR Going Live August 14, 2015
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Instructor Profile This webinar will explain about the FDA final rule on Electronic Medical Device Reporting so your company can be ready. 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.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Description
This webinar will explain about the FDA final rule on Electronic Medical Device Reporting so your company can be ready.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.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Why should Attend Being ready for the live eMDR is critical for your company. Mistakes in timing for submission, sending incorrect information and not being prepared to respond to an FDA inspector can cause a company needless time and money to correct issues.
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Objectives Basics of the Medical Device Reporting (MDR) Regulation Medical Device Reporting: Electronic Submission Requirements Final Rule Actions that Firms Have to Take Prior to Live Date Review the Basic Process for Preparing and Submitting Electronic Medical Device Reports (eMDRs) Best Practices for Your Firm Using eMDR Timing for Submission to eMDRs Which System Works Best for Your Firm? Readiness for FDA Inspector
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
Who can Benefit
Complaint handling units Auditors Compliance officers Consultants/service providers IT department supporting complaint handling Regulatory affairs reporting units
www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com
How this Webinar Works Username and Password will be sent to you 24 hours prior to the webinar Presentation handouts in pdf format will be mailed to you Login to the session using the username and password provided to you Get answer to your queries through interactive Q&A sessions via chat
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www.onlinecompliancepanel.com | 510-857-5896 | customersupport@onlinecompliancepanel.com