FDAnews Announces — Managing Medical Device Complaints Webinar, May 19, 2016

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Manufacturers need to establish top-rung complaint procedures as well as creating records and documents that ensure smoothly functioning QMS along with FDA compliance. Join industry expert Dan O’Leary on May 19 for an in-depth review and analysis of FDA inspection techniques, QSIT and warning letters.

Manufacturers need to establish top-rung complaint procedures as well as creating records and documents that ensure smoothly functioning QMS along with FDA compliance. Join industry expert Dan O’Leary on May 19 for an in-depth review and analysis of FDA inspection techniques, QSIT and warning letters.

Managing Medical Device Complaints
May 19, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/managingmdcomplaints        

What does the FDA really expect for complaint handling?

How should manufacturers implement — and measure — the effectiveness of a complaint handling system?

Why is Europe even more stringent than the U.S. when it comes to complaint management?

Join industry expert Dan O’Leary on May 19 as he provides practical, real-world tips on the:

  • QSR definition of a complaint
  • Requirements to investigate a complaint
  • Qualification requirements for people who investigate complaints
  • Data elements for every complaint investigation
  • Effect of UDI on these required records
  • Connection between complaints and medical device reports
  • Connection between complaints and risk management
  • Differences in ISO 13485:2003 and ISO 13485:2016
  • Trend analysis requirements in the EU Vigilance system and when to report complaints

Bonus Material — Attendees receive a checklist based on QSR, Warning Letters, and QSIT to help ensure compliance.

Attendees will come away from this webinar with a better understanding of this often complicated process and

  • Establish top-rung complaint procedures
  • Create records and documents to ensure smooth functioning of QMS and FDA compliance

Register today for a concrete understanding of how complaint files are managed across both domestic and international facilities.

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. He has a Masters Degree in Mathematics; 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:
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
  • Complaint Handling Specialists
  • Data Analysts
  • Adverse Event Specialists

Webinar Details:
Managing Medical Device Complaints
May 19, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/managingmdcomplaints            

Tuition:
$287 per site

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