Corrective Actions ? Current ISO 13485 auditor’s hot button, and FDA expectation as well

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Category Medical Device

Deadline: July 14, 2015 | Date: July 14, 2015

Venue/Country: Online, U.S.A

Updated: 2015-06-30 16:25:32 (GMT+9)

Call For Papers - CFP

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, making sure your system does robust corrections and corrective actions is a must.

Why you should attend :

For many year, early in the life of ISO 9001 and ISO 13485, it took 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 now 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!

Description of the topic

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.

Areas Covered In the Seminar:

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

Where does Preventive Action fit in

Examples of Containment actions

Who will benefit

This webinar will provide valuable assistance to all personnel in:

Quality Management

CAPA coordinators

Quality Engineers

Engineers doing Corrective Actions

Operations managers

Manufacturing managers and Engineers

Quality auditors

Medical device Consultants

Free documents

Sample Corrective and Preventive Action form

Sample Corrective and Preventive Action Log Form

Webinar Includes:

Q/A Session with the Expert to ask your question

PDF print only copy of PowerPoint slides

60 Minutes Live Presentation

Certificate of Attendance