FDAnews Announces — Setting and Measuring Quality Objectives for…

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Setting and Measuring Quality Objectives for Medical Devices
**An FDAnews Webinar**
June 14, 2018 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/qualityobjectivesmd

Devicemakers who fail to implement or communicate quality policy or quality objectives risk warning letters or worse. Why take the risk when help is at hand?

FDAnews has reached out to Dan O’Leary, one of our most popular presenters, to break down what the FDA requires and steer manufacturers to the painless path to compliance. Attendees are on their way in only 90 minutes, confident that they’ll understand:

  •     QSR requirements for the Quality Policy and Quality Objectives
  •     Methods the FDA investigator uses to verify compliance
  •     Additional requirements from ISO 13485:2016
  •     Sample Quality Policies illustrating the requirements
  •     Methods to develop Quality Objectives from the Quality Policy
  •     How to describe of the three types of metrics
  •     Use of Excel to develop a graphical approach to the metrics
  •     And much more!

Participants will receive a checklist to help ensure the system is prepared for the next FDA Inspection, Notified Body audit, or MDSAP audit.

Compliance is a big reason to master quality implementation and communication, but not the only one. Top quality leads to smoother production, greater patient safety, lessened liability and long-run profits.

Meet the Presenter:
Dan O’Leary is 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 experience in quality, operations, and program management in regulated industries including aviation, defense, medical devices, and clinical labs. 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:
This presentation focuses on Quality Policy, Quality Objectives, and associated metrics, subjects of particular interest to:

  •     QA/QR/QC
  •     Production managers
  •     QMS process managers
  •     Continuous improvement specialists
  •     Quality engineers
  •     Management representatives
  •     Management review attendees
  •     Consultants

Webinar Details:
Setting and Measuring Quality Objectives for Medical Devices
**An FDAnews Webinar**
June 14, 2018 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/qualityobjectivesmd

Tuition:
$287 per site

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