Strategies for an Effective Root Cause Analysis and CAPA Program

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

Instructor Profile:

Jeff Kasoff, RAC, is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Jeff is responsible for oversight of corporate compliance with domestic and international regulations, preparation of submissions, and is primary liaison with regulatory agencies and notified bodies. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Jeff received his Regulatory Affairs Certification in 1996.

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