Understanding Nonconforming Device Products - Webinar CD/Transcript

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Understanding Nonconforming Device Products

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, you 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 as he helps you understand the requirements and shows you how to implement them. Using examples from recent warning letters he will help you learn from mistakes and inform you of the issues investigators identify during an inspection.

In 90 minutes you 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
  • Quality Managers
  • Quality Engineers
  • Quality inspection and test managers
  • Production Managers
  • Production Supervisors
  • Manufacturing Engineers
  • Regulatory affairs and compliance professionals

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.