Corrective Actions - Current expectation of ISO 13485 and FDA auditors

Duration: 60 Minutes
Earlier, ISO auditors have trained companies on the difference between Corrections (fixing the problem) and Corrective Actions, fixing the root cause of the problem. However, now, although corrections are usually being done, they are done under other portions of ISO 13485, such as control of nonconforming product and customer feedback/ complaints. These often have very little visibility in the Corrective Action system, and generally do not address all containing or correcting quality system issues that are often a major part of a Corrective Actions system. So now ISO auditors, or at least ISO 13485 Notified Body auditors expect companies to document and provide evidence that they are doing containment or correction quickly.
ISO 13485 and FDA auditors
Instructor: Betty Lane
Product ID: 500656

Even though ISO 13485 requirements for Corrective Actions stress finding and correcting the root cause of a non-conformity, which is the essence of Corrective Action, that is not enough. Containment and Correction must now be an integral part of your system. With FDA's increasing emphasis on enforcement, doing robust corrections and corrective actions is a must.

Why Should you Attend:
This presentation will benefit all those involved with internal or supplier corrective actions. If you issue corrective actions, you need to know what to expect of those assigned corrective actions, and often help the assignee understand the expectations. If you are assigned to complete a corrective action, you need to know what is to be expected of you in terms of investigation, analysis, and both correction and corrective actions. If you manage the corrective action system or those doing corrective actions, it is also important that you understand what you outside auditors expect of a strong CAPA system. So that means almost anyone working within a medical device quality system could benefit from understanding the CAPA system.

Objectives of the Presentation:
This presentation will provide an understanding of the current expectations of ISO 13485 notified body auditors regarding containment or correction of a nonconformity. Information will be provided to make sure your Corrective Action system meets current ISO 13485 expectations, which also will give you a strong Corrective Action system for meeting FDA Corrective Actions expectations.

We will cover:
  • Overview of CAPA system for Current ISO 13485 compliance
  • Why Containment and Correction have been overlooked
  • Why this is a hot item with ISO auditors
  • What is the difference between correction and corrective action
  • What kind of containment can be done for Quality System nonconformities
  • Defining and documenting Containment actions - Quickly
  • Where does Preventive Action fit in
  • Examples of Containment actions
Who can Benefit:
This webinar will provide valuable assistance to all professionals in:
  • Quality Management
  • CAPA coordinators
  • Quality Engineers
  • Engineers doing Corrective Actions
  • Operations managers
  • Manufacturing Engineers
  • Quality auditors
  • Medical device Consultants
Recorded Session for one participant
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Instructor Profile:
Betty Lane has over 30 years’ experience in Medical Device quality assurance and regulatory affairs. She is the founder and President of Be Quality Associates, LLC, a consulting company helping small and medium sized medical device and diagnostic companies implement and improve their quality systems. Her work enables companies to manage their business in compliance with FDA and ISO 13485 requirements, as well quality system requirements for other area such as Europe and Canada. Her background in digital systems engineering enables her to facilitate design controls and software validation. Her areas of expertise include training, auditing, supplier management, document and records management, design controls, and software validation.

Betty’s training experience includes over 25 years of training on all areas ISO 13485 and FDA cGMP, in companies, and for AAMI, ASQ biomedical division, and ASQ sections. She has taught courses in medical quality and regulatory affairs at Northeastern University, Boston, MA. Betty is active in her local section of the American Society for Quality and is also a member of the Association for the Advancement of Medical Instrumentation (AAMI), The Society of Women Engineers and the IEEE. Betty has degrees in engineering from Rensselaer Polytechnic Institute (RPI), and an MBA from Northeastern University.
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