FDAnews Announces The Correction and Removals Guidance: Understanding and Implementation Webinar, Jan. 19, 2017

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How can manufacturers tell the differences between a device enhancement — which is not reported to the FDA — a reportable activity and reporting exceptions? Join industry expert Dan O’Leary on Jan. 19 for an in-depth explanation starting with the difference between an enhancement and a reportable change — a change the FDA would classify as a recall.

The Correction and Removals Guidance:
Understanding and Implementation
**An FDAnews Webinar**
Jan. 19, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/correctionremovalsguidance        

How can manufacturers tell the differences between a device enhancement — which is not reported to the FDA — a reportable activity and reporting exceptions?

It’s not easy. There’s still confusion about records and reporting two years after the final guidance was released.

Understanding the definitions is hard enough… but when those definitions don’t agree across the many applicable regulations device-makers need help.

Join industry expert Dan O’Leary on Jan. 19 for an in-depth explanation. Dan will start with the difference between an enhancement and a reportable change — a change the FDA would classify as a recall. Then, he’ll clarify which changes are not reportable. He’ll explain these ideas using examples, warning letters and recalls.

After attending this 90-minute webinar attendees will be able to:

  • Understand the regulation for correction and removal in Part 806
  • Learn about the guidance document, its intention, and it application
  • Understand the reporting exemptions
  • Learn the requirements for records and their content
  • Understand how FDA would classify the report as a recall
  • Know their obligations to manage a recall

Bonus Materials — All attendees will receive the following materials to help implement the regulations:

  • A copy of the final guidance document
  • A copy of the Corrections and Removal regulation, formatted for easier reading
  • An Excel spreadsheet that will help determine if the event is reportable
  • A comparative analysis of the definitions in the Recall regulation (Part 7) and the Correction and Removal regulation (Part 806)

Register today and gain a better understanding of how records and reporting relate to corrections and removal.

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 year’s experience in quality, operations and program management in regulated industries including: aviation, defense, medical devices and clinical labs. He has a Master’s 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:

  • Quality Assurance
  • Design Engineers
  • Design Project Managers
  • Regulatory Affairs
  • Legal counsel
  • Complaints specialists
  • Medical device reporting specialists
  • Field change specialists
  • Risk Management specialists

Webinar Details:
The Correction and Removals Guidance:
Understanding and Implementation
**An FDAnews Webinar**
Jan. 19, 2016 — 1:30 p.m. – 3:00 p.m. ET
http://www.fdanews.com/correctionremovalsguidance        

Tuition:
$287 per site

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