CAPA Systems for Medical Device Manufacturers

Course Description:

Implementing an effective system for corrective action and preventive action can be a major challenge. FDA illustrates the point in its published information on Warning Letters. FDA cited the CAPA subsystem in 81 of 89, 91%, of Warning Letters issued in 2010, the most recently available data. The CAPA subsystem includes nonconforming material, corrective and preventive action, and complaints (820.90, 820.100, 820.198). The trend continues in recent warning letters.

This interactive two-day course provides the tools you need to develop and implement an effective medical device CAPA system. In addition to FDA QSR, the course covers the corresponding requirements in ISO 13485 as well as the linkage to risk management in ISO 14971. Corrective action requirements extend beyond the basic QMS to include field actions, so the course includes adverse event reporting, Corrections & Removals, Field Safety Corrective Actions, and Field Safety Notices.

CAPA does not stand alone; it is most effective when it is an integral part of the Quality Management System and influences all of the other subsystems. The overarching objective of the course helps the participants develop the tools and methods. The course utilizes a broad variety of available material including FDA guidance documents, Global Harmonization Task Force (GHTF) guidance documents, ISO guidance documents, and European Union medical device guidance documents (MEDDEV).

Course Objectives:

• Develop the tools and methods to create an integrated CAPA system.
• Explain the difference between correction, corrective action, and preventive action and understand why they are different.
• Gain knowledge of the medical device CAPA regulatory requirements including FDA QSR and ISO 13485.
• Evaluate common problem solving and improvement methodologies, explain the quality tools, and apply them to the CAPA system.
• Understand “appropriate statistical methodology” to analyze data and identify existing and potential causes of quality problems.
• Identify the linkages between complaints, corrective action, and risk management.
• Understand the regulatory requirements for corrective actions in the field for both the US and the EU.