Nonconforming Product Problems in Medical Devices

Nonconforming Product Problems in Medical Devices - Webinar CD/Transcript

$347.00
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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.

Order Today — Avoid crucial regulatory mistakes.

Yes, mistakes happen. It’s human nature. So be smart, be preemptive. When finished device products — or in-process devices, device components, returned devices or specific manufacturing materials — don’t measure up, learn how to deal with them in ways that save money and keep the FDA off your corporate back.

This CD and transcript set will help you:

  • Understand best practices for managing nonconforming product.
  • Discover the crucial differences between a correction and a corrective action.
  • Properly document decisions to use nonconforming product, using FDA-tested examples.
  • Understand the need for retesting and reevaluation after rework.
  • Know the role of quality data trending using appropriate statistical techniques in 820.100 and how this applies to nonconforming product.
  • Reduce the chance that a nonconforming product investigation will lead to corrective action.
  • Explain to FDA investigators why you were justified in using a nonconforming product for another use.

Order Now — Avoid Crucial Regulatory Mistakes

  • Medical device manufacturing and executives
  • QA/QC managers and directors
  • Production managers
  • Production supervisors
  • Quality inspection and test managers
  • Supply chain specialists
  • Process development staff
  • Compliance officers
  • Training managers
  • Regulatory affairs and compliance professionals

Learn from an expert in the field
Dan O’Leary 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 is president of Ombu Enterprises, a consultancy focused on operational excellence and regulatory compliance serving small manufacturing companies. 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.