Comprehensive CAPA
This deep dive into CAPA will allow you to build on your existing problem-solving skills and learn how to use a structured process improvement approach to CAPA. Methods used align with regulatory requirements and industry best practice for CAPA, giving you the knowledge to execute, implement or improve a CAPA process.
Example topics include how to define the problem, understand the impact, conduct investigations, perform root cause analysis and determine the actions needed to resolve the problem. You will learn how to monitor CAPA progress, verify effectiveness of actions taken,and better structure their CAPA documentation.
This course is fully interactive and you will work through the different phases of a CAPA using a case study.
At a Glance
- Target Audience: This program is designed for medical device professionals and others in related departments interested in understanding the CAPA processes from end-to-end.
- Learning Level: Basic
- Total Length of Course: 8 Hours
- RAC Points: 8
- This course was developed by Meddev Solutions
Learning Objectives
Upon completion of this course, participants should be able to:
- Demonstrate practical knowledge on how to structure CAPA
- Appropriately document problem definitions
- Know how to perform root cause analysis and associated verification
- Develop and verify appropriate solutions prior to implementation
- Know how to effectively document CAPA
- Understand how to assess overall CAPA effectiveness
- Outline the phases and documentation in accordance with industry best practice and regulatory requirements
- Module 1: Introduction and Requirements
- Module 2: Defining the Problem
- Module 3: Contain and Investigate
- Module 4: Implement and Verify
- Module 5: Planning and Management
