Integrating Risk Management into the CAPA System

This webinar will explain what FDA expects in incorporating risk in the CAPA process, what strategies can be used to assign resources to CAPA activities, and how to manage multi-level CAPA processes so that they will not run afoul of the FDA during inspections

Why Should You Attend:

CAPA findings in FDA inspections continue to be among the highest observations cited by investigators. This fact means that manufacturers should focus efforts on improving CAPA systems which are important to correcting and improving quality systems. FDA has provided information explaining that risk is an important consideration in the CAPA process. They do not however, provide any guidance on how risk is included in this important process. Additionally, more information is flowing out of FDA indicating that risk is becoming an additional focus of the agency, such as in the recent report on risk communication.

This webinar will examine regulatory and standards requirements of CAPA processes as they relate to risk management. It will discuss multi-level CAPA processes, and assigning resources to CAPA investigations, and corrective and preventive actions. This webinar will also examine the requirements for CAPA effectiveness checks, as well as integrating risk management into recall decisions and health hazard evaluations.

Areas Covered in the Webinar:

• How to establish a multi-level CAPA process that meets requirements
• Using risk management to assign CAPA resources and priorities
• Updating risk management files with information from CAPA process
• Risk management and CAPA effectiveness checks
• How risk management integrates with recall decisions and health hazard evaluations
• Risk management and supplier corrective actions

Who Will Benefit:

This webinar is appropriate for all personnel associated with the CAPA process. The program is not limited to those with direct operation of CAPA, but also includes all personnel that may be affected by CAPA activities.

• Quality Auditors
• Quality Engineers
• CAPA Managers
• Supplier Quality Personnel
• Risk Managers
• Process Engineering Personnel