Corrective Action & Preventive Action for Medical Devices - Webinar CD/Transcript

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Corrective Action & Preventive Action for Medical Devices: Implementing the Steps to Prevent a Warning Letter

Approximately 70% of warning letters citing QSR are for corrective and preventive action. QSIT inspections always include corrective and preventive action, providing more opportunity to uncover problems, this does not explain the predominance of CA&PA citations over time.

One problem is not distinguishing between corrective action (CA) and preventive action (PA).

The methods share techniques and tools — but they are different and have different purposes. Confusing the methods or lumping them together is a major source of problems.

Join industry expert Dan O’Leary as he identifies the most frequently cited steps in the corrective and preventive action processes, explains the issues that warning letters reveal and provides information to avoid these problems.

After this 90-minute session you’ll:

  • Learn the three parts of the FDA’s corrective and preventive action system
  • Understand the steps in the FDA’s corrective action and preventive action processes
  • Learn the QSIT expectations for each step
  • Review warning letter citations and understand the FDA’s reasoning
  • Understand how to correct similar problems in your QMS
  • Learn how to prevent the problem initially

BONUS: Participants receive a checklist designed to help implement effective corrective and preventive action systems. The checklist addresses each of the steps and includes recommendations for the procedure as well as recommendations for forms and other record keeping.

Order today and implement compliant systems to withstand an FDA inspection and manage efficient and effective improvement.

  • Quality managers
  • Process owners
  • Investigators assigned to improvement opportunities
  • Quality engineers
  • Manufacturing engineers
  • Supervisors
  • Internal quality auditors
  • Documentation specials

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.