Elements of a Corrective and Preventive Action (CAPA) Program and Uses of CAPA Data

         Year after year, CAPA is the subsystem cited most frequently during FDA inspections. A robust Corrective and Preventive Action (CAPA) program is of the utmost importance to a medical device manufacturer. A system that identifies and eliminates non-conformances and potential non-conformances enables both regulatory compliance and cost savings. This session will discuss the importance, requirements, and elements of a CAPA program, as well as describing the uses of CAPA data. Additionally, the application of risk management to a CAPA program will be reviewed, and a specific risk management system explained.

         This webinar will identify the most common elements identified as deficient by FDA, and provide recommendations for how to provide clear, concise documentation to assure FDA your firm has addressed these in your quality system. This webinar also provides recommended forms to assure that in addition to being able to illustrate compliance, your firm's CAPA system is useful and meaningful.

         This webinar will identify the most common elements identified as deficient by FDA, and provide recommendations for how to provide clear, concise documentation to assure FDA your firm has addressed these in your quality system. This webinar also provides recommended forms to assure that in addition to being able to illustrate compliance, your firm's CAPA system is useful and meaningful.

• Regulatory Requirements 1) FDA QSR & 2) ISO 13485
• Elements of a cross-procedural CAPA program
• Applications of CAPA
• CAPA Data, and best practices for its use
• Application of risk management to CAPA program

This webinar will provide valuable assistance to all regulated companies, since a CAPA program is a requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. The employees who will benefit include:

• QA management
• CAPA coordinator
• Regulatory Affairs management
• Executive management
• Consultants
• Quality system auditors

• Quality and Regulatory Network Group
• Corrective and Preventive Action Group
• Medical Devices Group
• American Society for Quality
• Regulatory Affairs Professional Society

Those individuals who require a more in depth understanding of corrective and preventive actions, or those who are or will be undertaking root cause investigation.