When is Corrective Action Not Enough - Doing and Documenting Corrections is an ISO 13485 Expectation April 4, 2013

This ISO 13485 compliant CAPA training for medical device companies will explain current expectations of ISO 13485 notified body auditors regarding containment or correction of a nonconformity. You will learn methods of documenting containment and correction activities within your Corrective Action system.

Why Should You Attend:

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!

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.

Learning objectives:

- Developing or updating a best-practice Corrective Action system.
- Complying with ISO 1385 Notified Body audits.
- Complying with FDA requirements for corrections and corrective actions.
- Methods of documenting containment and correction activities within your Corrective Action system.
- Knowing how much to do and when

Official Website: http://www.complianceonline.com/ecommerce/control/trainingFocus/~product_id=702796?channel=yahooevent