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FDAnews Announces — MDR Adverse Event Codes for Devicemakers Webinar, Aug. 14, 2018
Date:7/31/2018

MDR Adverse Event Codes for Devicemakers

**An FDAnews Webinar**

Aug. 14, 2018 — 1:30 p.m. – 3:00 p.m. ET

http://www.fdanews.com/mdradverseeventcodes    

Devicemakers know the deadline is looming for revisions to how MDRs are submitted to the FDA.

What many devicemakers don’t know is the secret to an easier transition.

It’s a free tool called eSubmitter and it can make completing Form 3500A a snap. Dan O’Leary is going to show attendees how to use it.

Mark the calendar for Tuesday, Aug. 14, when top-rated presenter Dan O’Leary walks devicemakers through eSubmitter’s twists, turns and tricks. In this fast-paced 90-minute webinar, attendees will start with the basics and move on to mastery:

  •     Criteria for a mandatory medical device report
  •     Required records and their content
  •     The reporting system and associated acknowledgements
  •     When codes apply in eSubmitter
  •     The IMDRF harmonization plan: Which parts the FDA has adopted
  •     Selecting the appropriate codes
  •     Transition dates: Avoiding FDA rejection of obsolete codes
  •     And much more

If eMDR submitters must get on top of coding changes and implementation dates ASAP. This presentation readies them for implementation well in advance of the effective date and gives them crucial background to help them implement the new coding system without a hitch.

Meet the Presenter:
Dan O’Leary is President of Ombu Enterprises LLC, a company offering Operational Excellence training focusing on analytic skills and a systems approach to operations management. Mr. O’Leary has 30+ years’ experience in quality, operations, and program management in regulated industries including medical devices, clinical labs, aviation and defense. He is an ASQ-certified Biomedical Auditor, Quality Auditor, Quality Engineer, Reliability Engineer, and Six Sigma Black Belt; and is certified by APICS in Resource Management.

Who Will Benefit:
Individuals involved in complaint management and adverse event reporting should sign up. In particular persons in the following job titles will benefit:

  •     Quality Managers
  •     Quality Engineers
  •     Complaint Analysts
  •     Adverse Event Managers
  •     Medical Affairs Managers
  •     MDR Investigators
  •     MDR Preparers
  •     MDR Submitters
  •     IT Professionals who maintain eSubmitter

Webinar Details:
MDR Adverse Event Codes for Devicemakers
**An FDAnews Webinar**
Aug. 14, 2018 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/mdradverseeventcodes    

Tuition:
$287 per site

Easy Ways to Register:
Online:     http://www.fdanews.com/mdradverseeventcodes                            
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.

Read the full story at https://www.prweb.com/releases/fdanews_announces_mdr_adverse_event_codes_for_devicemakers_webinar_aug_14_2018/prweb15661439.htm.


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