FDAnews Announces — Medical Device Reporting: A Practical Approach to Pass an FDA Inspection Webinar, July 21, 2016

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Is the MDR process up to the rigors of an FDA inspection? Join industry expert Dan O’Leary, President of Ombu Enterprises, LLC, on July 21 as he explains MDR issues and provides advice on implementing an effective MDR system.

Medical Device Reporting:
A Practical Approach to Pass an FDA Inspection
**An FDAnews Webinar**
July 21, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/mdreporting

Is the MDR process up to the rigors of an FDA inspection?

Are definitions and specific information included in the reports?

What else are the FDA inspectors really looking for?

Join industry expert Dan O’Leary, President of Ombu Enterprises, LLC, on July 21 as he explains MDR issues. In 90 minutes he will cover:

  •     The required content for MDR procedures
  •     The reporting criteria for an MDR
  •     Special cases raised in the guidance documents, such as contract manufacturers
  •     When the initial MDR is due as well as any followups
  •     The current submission method — eMDR
  •     And more…

Register today and learn how to implement an effective MDR system.

Meet the Presenter:
Dan O’Leary is the President of Ombu Enterprises, LLC, a company offering training and execution in Operational Excellence, focused on analytic skills and a systems approach to operations management. Dan has more than 30 years of experience in quality, operations, and program management in regulated industries including, aviation, defense, medical devices and clinical labs.

Who Will Benefit:
Creating the procedures, developing the records, and ensuring compliance is a team effort involving many functions and disciplines. This includes people in the following roles:

  •     Quality Managers
  •     Quality Engineers
  •     Quality Auditors
  •     Regulatory Managers
  •     MDR Handling Specialists
  •     Complaint Handling Specialists
  •     Risk Managers
  •     Data Analysts

Webinar Details:
Medical Device Reporting:
A Practical Approach to Pass an FDA Inspection
July 21, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/mdreporting

Tuition:
$287 per site

Easy Ways to Register:
Online: http://www.fdanews.com/mdreporting            
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
+1 (703) 538-7665
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