FDAnews Announces — Understanding Nonconforming Device Products Webinar, Jan. 26, 2016

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Every medical device manufacturer has to deal with nonconforming product — but based on the number of warning letters citing 21 CFR 820.90, it’s clear many don’t know how. Join industry expert Dan O’Leary, President of Ombu Enterprises, LLC on Jan. 26 as he helps manufacturers understand the requirements and how to implement them.

Understanding Nonconforming Device Products
Jan. 26, 2016 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/understandingnonconformingdeviceproducts

Every medical device manufacturer has to deal with nonconforming product — but based on the number of warning letters citing 21 CFR 820.90, it’s clear many don’t know how.

Nonconforming product is one of the top the 10 most frequently cited sections in device warning letters.

To develop good procedures, manufacturers must understand the regulations. That can be very confusing, because the rules are not well defined in either FDA QSR or ISO 13485:2003. In addition, the recordkeeping requirements are spread across QSR, making it difficult to identify them. There are also major connections to the Device History Record (DHR) and corrective action.

Join industry expert Dan O’Leary, President of Ombu Enterprises, LLC on Jan. 26 as he helps manufacturers understand the requirements and how to implement them. Using examples from recent warning letters attendees will learn from mistakes and the issues investigators identify during an inspection.

In 90 minutes attendees will learn:

  • The definition of nonconforming product
  • The standard dispositions and their definitions
  • The difference between correction and corrective action as well as the types of correction
  • The DHR requirements for nonconforming product rework — they are not included in 820.184
  • How to document a decision to use nonconforming product
  • The need for retesting and reevaluation after rework and its relationship to acceptance activities
  • How to link the investigation of nonconforming product to corrective action

Bonus Material:
Attendees will receive a checklist based on the regulations, warning letters, and QSIT to help ensure compliance.

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 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:
People in the following roles can especially benefit from the knowledge in this webinar:

  • Quality Managers
  • Quality Engineers
  • Quality inspection and test managers
  • Production Managers
  • Production Supervisors
  • Manufacturing Engineers
  • Regulatory affairs and compliance professionals

Webinar Details:
Understanding Nonconforming Device Products
Jan. 26, 2016 — 1:30 p.m. – 3:00 p.m. EST
http://www.fdanews.com/understandingnonconformingdeviceproducts

Tuition:
$287 per site

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