FDAnews Announces: Top 7 Keys to eMDR Success: The Deadline is Near, Are You Ready? Webinar, March 31, 2015

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Devicemakers must take steps now to secure a production account for submitting electronic Medical Device Reports (eMDRs), ahead of an Aug. 14, 2015 deadline for compliance. In providing guidance on the rule, the FDA emphasizes that eMDRs include the same information as paper MDRs.

Top 7 Keys to eMDR Success:
The Deadline is Near, Are You Ready?
**FDAnews Webinar**
March 31, 2015 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/KeyseMDRSuccess

The deadline looms.

Devicemakers must take steps now to secure a production account for submitting electronic Medical Device Reports (eMDRs), ahead of an Aug. 14, 2015 deadline for compliance. The FDA set the deadline in a final rule issued Feb. 14, 2014.

In providing guidance on the rule, the FDA emphasizes that eMDRs include the same information as paper MDRs. To begin submitting eMDRs, a manufacturer needs to:

  •     Request a Web Trader account from the FDA’s Electronic Submissions Gateway;
  •     Submit a Letter of Non-Repudiation to the agency;
  •     Obtain a personal digital certificate; and
  •     Submit a mock report as test data.

Devicemakers have two choices for preparing eMDRs. One option is the FDA’s free eSubmitter software, by which manufacturers can manually enter case data for transmission to the agency. The other option is Health Level Seven (HL7) Individual Case Safety Reporting, which allows for batch report preparations.

But unlike eSubmitter, HL7 does not permit users to print the report. Because of this, “entities who choose this option are encouraged to develop systems that can save or print the resultant report and that can encode attachments into their eMDRs,” the guidance says.

Which way should a company go? What are the plusses and minuses of each option?

Attendees will learn:

  •     How to understand the three very different ways to transform data into an XML file. How to select the one that’s right for an organization.
  •     How to become a “transaction partner” with the FDA. Get it wrong and get off on the wrong foot from the very beginning.
  •     Ways to leverage the ACK (Acknowledgements) process to demonstrate compliance with the FDA, which one of three paths should each manufacturer choose, and how to handle a “negative” acknowledgement from the FDA.
  •     Why it is critical to test now before the FDA tests manufactureres. Learn which of the six testing methods is best for an organization.
  •     Lift the best ideas from proven best practices of successful companies. Their pain can be another’s gain.
  •     How to steer clear of deadline and other time-related problems.
  •     The end is just the beginning. Remember, what works in August may not work next January.

Meet the Presenter:
Deborah Kacera, Regulatory & Industry Strategist, Pilgrim Quality Solutions is a “go to” source. Outside of the FDA, she’s one of the strongest subject matter experts within industry. Prior to working at Pilgrim for the past sixteen years, she time as the manufacturing manager at MTD Technologies, General Motors and McDonell AirCraft.

Who Will Benefit:

  •     Medical device manufacturing and executives
  •     Auditing and compliance officers
  •     QA/QC managers and directors
  •     Production managers
  •     Production supervisors
  •     Process development staff
  •     Training managers
  •     Regulatory affairs professionals
  •     Executive management
  •     General/corporate counsel
  •     Personnel new to the industry

Conference Details:
Top 7 Keys to eMDR Success:
The Deadline is Near, Are You Ready?
**FDAnews Webinar**
March 31, 2015 — 1:30 p.m. – 3:00 p.m. EDT
http://www.fdanews.com/KeyseMDRSuccess

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/KeyseMDRSuccess
By phone: 888-838-5578 or 703-538-7600

About FDAnews:
FDAnews is the premier provider of domestic and international regulatory, legislative, and business news and information for executives in industries regulated by the US FDA and the European Medicines Agency. Pharmaceutical and medical device professionals rely on FDAnews' print and electronic newsletters, books and conferences to stay in compliance with international standards and the FDA's complex and ever-changing regulations.

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Michelle Butler
FDANEWS
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