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

Overview

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 nonconformances and potential nonconformances enables both regulatory compliance and cost savings.

Why Should You Attend

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.

Areas Covered in this Webinar

Regulatory Requirements

FDA QSR

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

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