Best Practices for FDA and Iso 13485 Corrective Actions

Carolyn Troiano

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For many years, early in the life of ISO 9001 and ISO 13485, it to a lot of education on the part of ISO auditors to teach companies the difference between Corrections (fixing the problem) and Corrective Actions, fixing the root cause of the problem. And companies learned that well, and generally meeting expectations of their ISO auditors. However, now, although corrections are usually being done, they are usually done under other portions of ISO 13485, such as control of nonconforming product and customer feedback and complaints. These often have little visibility in the Corrective Action system, and generally do not address at all containing or correcting quality system issues that are often a major part of a Corrective Actions system. So ISO auditors, or at least ISO 13485 Notified Body auditors, are expecting that companies now document and provide evidence that they are doing containment or correction, and quickly as well! And the approach to the actions take must be consistent with the risk of the issue.

Course Objective

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 robust Corrective Action system for meeting FDA Corrective Actions expectations.

Course Outline

  • 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 really the difference between correction and corrective action
  • What kinds of containment can be done for Quality System nonconformities
  • Defining and documenting Containment actions - Quickly
  • Using Risk as part of the CAPA system
  • Where does Preventive Action fit in
  • Examples of Containment actions

Target Audience

This webinar will provide valuable assistance to all personnel in:

  • Quality Management
  • CAPA coordinators
  • Quality Engineers
  • Engineers doing Corrective Actions
  • Operations managers
  • Manufacturing Engineers
  • Quality auditors
  • Those new to quality

Webinar Events
Live -Coming soon!

Training CD-DVD

Physical CD-DVD of recorded session will be despatched after 72 hrs on completion of payment

Recorded video

Recorded video session

Speaker: Carolyn Troiano,

Carolyn Troiano has more than 30 years of experience in computer system validation in the pharmaceutical, medical device, animal health, tobacco and other FDA-regulated industries. She is currently an independent consultant, advising companies on computer system validation and large-scale IT system implementation projects. During her career, Carolyn worked directly, or on a consulting basis, for many of the larger pharmaceutical companies in the US and Europe. She developed validation programs and strategies back in the mid-1980s, when the first FDA guidebook was published on the subject, and collaborated with FDA and other industry representatives on 21 CFR Part 11, the FDA's electronic record/electronic signature regulation. Carolyn has participated in industry conferences, providing very creative and interactive presentations. She is currently active in the PMI, AITP, and RichTech, and volunteers for the PMI's Educational Fund as a project management instructor for non-profit organizations.

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