Comprehensive CAPA

Build on existing problem-solving skills and explain how to use a structured process improvement approach to CAPA.

Our methods are designed to align with regulatory requirements and industry best practices for CAPA, equipping you with the expertise to execute, implement, or enhance a CAPA process.

Topics covered include problem definition, assessing impact, conducting investigations, performing root cause analysis, and determining the necessary actions to address issues. You’ll also learn how to monitor CAPA progress, verify the effectiveness of actions taken, and better structure CAPA documentation.

This course is fully interactive, allowing participants to engage with each phase of the CAPA process through a detailed case study.

Course Agenda

This training course is broken down into topics to enhance clarity and facilitate learning.

Module 1

Introduction and Requirements

History and Definition of CAPA
Regulatory Requirements
When to do CAPA
Industry Approaches to CAPA

Module 2

Defining the Problem

Problem Statement
Problem Definition
Problem Definition Tools
Risk/Impact Analysis

Module 3

Contain and Investigate

Correction and Containment
Investigation
Data Analysis
Root Cause Determination
Application

Module 4

Implement and Verify

Corrective and Preventive Actions
CAPA verification
CAPA closure
Case Study: Bobs Bakery

Module 5

Planning and Management

CAPA Documentation
CAPA Planning
Timelines
Regulatory Considerations

Learning Objectives

  • Demonstrate practical knowledge on how to structure CAPA
  • Explain how to document adequate problem definitions
  • Know how to perform root cause analysis and associated verification
  • Develop and verify appropriate solutions prior to implementation
  • Show and apply how to adequately document CAPA
  • Understand how to assess overall CAPA effectiveness
  • Outline the phases and documentation in accordance with industry best practice and regulatory requirements

Price

Single Seat Price

€645 pp

Organisational group rates

3 -5 attendees receive 15% discount
6+ attendees receive 20% discount
Email training@trinzo.com for a unique discount code

What’s Included?

Access to the Trinzo Training Portal*

Fully interactive course as you work through a case study

Downloadable resources

CoE Accredited Certificate of Completion

Knowledge checks

*If there is a preference to embed this course within your global LMS system, we can customise it to match not only your brand, but also your culture and values.

Technology Requirements

Operating system

Windows requirements:
Windows 7 or later

Mac requirements:
Mac OS X Yosemite 10.10 or later

Linux requirements:
64-bit, Ubuntu 14.04+, Debian 8+,openSUSE 13.3+ or Fedora Linux 24+

Processor

Windows requirements:
Intel Pentium 4 or later

Mac requirements:
Intel

Linux requirements:
Intel Pentium 4 or later

Internet Connection

Required

FAQ

Once your booking has been placed and confirmed, you will receive an email which contains your course overview, login details, course agenda and payment receipts. You can begin your training immediately!

On successful completion of the course, you will receive a certificate of completion that can be used to demonstrate your knowledge to your employers and Notified Bodies.

The fastest and easiest way to pay would be to use your company credit card. If you cannot do that, and you require a PO, please email our team at training@trinzo.com.

Yes of course. If you can no longer attend the course, you can transfer your place at no additional cost

Comprehensive CAPA

This deep dive into CAPA will teach you how to build on your existing problem-solving skills and explain how to use a structured process improvement approach to CAPA. The methods we use align with regulatory requirements and industry best practice for CAPA, giving you the knowledge to execute, implement or improve a CAPA process.

Duration - 4 hours

Training Style - Self-Paced