Strategies for an Effective Root Cause Analysis and CAPA Program

This webinar will provide valuable assistance to all regulated companies, a CAPA program is a requirement across the Medical Device, Diagnostic, Pharmaceutical, and Biologics fields. This session will discuss the importance, requirements, and elements of a root cause-based CAPA program, as well as detailing the most effective ways to determine root cause and describing the uses of CAPA data.

A robust Root Cause-based Corrective and Preventive Action (CAPA) program is of the utmost importance to a medical device manufacturer. A system that investigates, identifies and eliminates nonconformances and potential nonconformances enables both regulatory compliance and cost savings. This session will discuss the importance, requirements, and elements of a root cause-based CAPA program, as well as detailing the most effective ways to determine root cause and 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.

Areas Covered in the seminar:

• QSR and ISO 13485 requirements for CAPA.
• Methods and types of determination of root cause.
• Elements of a cross-procedural CAPA program.
• Applications of CAPA.
• CAPA data and its uses.
• Application of risk management to CAPA program.

Who Will Benefit:

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

• R&D Management
• Regulatory Management
• QA Management
• Consultants
• Quality System Auditors