Practical Guidance for Implementing and Maintaining eMDR via ESubmitter

1 Hour Video | Diane Sheffer, STERIS Corporation

While the August 2015 reporting deadline for eMDR submissions has passed, many quality professionals continue to struggle with the complex implementation and maintenance of an individual eSubmitter and Electronic Submission Gateway (ESG) account. The FDA stated that the electronic submission process will accelerate reporting procedures and decrease the burden of data entry; however, manufacturers have encountered significant burdens and road blocks simply trying to implement the reporting programs on their operating systems. As medical device quality teams continue to collect and report product complaints and adverse events, they must also explore options for implementing a reliable and accurate eMDR system.

  • eMDR decisions and first steps
  • Navigating the ESG Account Setup
  • CeSub eSubmitter and ESG error and issue management
  • Technical tips for eMDR quality teams

 

Participants that will find this webinar most beneficial will be those involved in medical device companies.  Job titles of attendees that will be most applicable for this session will be:

  • Quality Assurance
  • Quality Systems
  • Regulatory Affairs

 

Diane

Diane Sheffer, CISA, RAC
Senior Manager, Regulatory Affairs
STERIS Corporation

Speaker Credentials:

  • 30+ years in Medical Device Industry:  20+ in Information Technology and 10 in Regulatory Affairs
  • BS in Mathematics, RAC and CISA (Certified Information Systems Auditor) certified
  • Member of the AAMI Software Working Group and various AdvaMed user groups
  • Implemented the eMDR process for STERIS in 2008
  • Core member of the STERIS UDI Implementation team
  • Expertise in Software Validation

 

 


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