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QA/RA Consulting, Auditing & Training

Medical Device CAPA and Root Cause Investigation Training

Every RA/QA manager has struggled with repeat CAPAs. A problem you thought had been solved pops up again months later, but why? Persistent problems are not only annoying, they endanger patient safety, cost money, and redirect focus from other issues. Using workshops, case studies, and simulations, you'll learn how to use Corrective and Preventive Action (CAPA) as a program to correct and prevent product and quality problems, as well as root cause analysis as a methodology for finding the cause of product and quality problems. This course covers CAPA requirements from ISO 13485:2016 and US FDA, common root cause investigation tools, and how to prepare for an inspection of the CAPA process.

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Brief Overview of This Medical Device CAPA Training Class

SkillsLab Class ?

Class Content

In-Depth

Class Duration

5 Half-Day Sessions

Teaching Format

Live, Instructor-Led

Delivery Options

Virtual or In Person*

Certification of Completion

Yes

Continuing Education Units (CEUs)

2.5

* SkillsLab classes delivered in-person (private or public) are full-day sessions delivered over 3 consecutive days.

** Interested in private training for your team, virtually or in-person at your facility? See more details or ask us about it!

Upcoming Classes

Upcoming CAPA and Root Cause Investigation Training Courses

SkillsLab $3295

SkillsLab $3295

Course Code	Location	Class Begins	Class Ends	Daily Schedule	Course Delivery	Registration
CRF	VIRTUAL DELIVERY (Eastern time - PM)	21 Jul 2025	25 Jul 2025	1:00PM - 5:00PM Eastern US Time	Virtual	REGISTER
CRF	VIRTUAL DELIVERY (Eastern time - PM)	06 Oct 2025	10 Oct 2025	1:00PM - 5:00PM Eastern US Time	Virtual	REGISTER
CRF	VIRTUAL DELIVERY (Eastern time - PM)	13 Oct 2025	17 Oct 2025	1:00PM - 5:00PM Eastern US Time	Virtual - Spanish Delivery	REGISTER

GROUP DISCOUNT

Save up to

25%

Register 3 people, 4th attends free!

Free

*This offer cannot be combined with any other promotional offer(s).

Course Overview

How Deep Do You Need to Go?

This course provides a deep dive into the process, beginning with a solid problem definition statement, which is determined with data that can be used to verify the effectiveness of the implemented solution. Using workshops, case studies, and simulations, in this course you’ll work through the entire root cause analysis process, from creating a data-based problem statement, applying root cause (RC) tools, and conducting data analysis for verifying the cause to selecting the best solution and determining its effectiveness.

Course Overview

SkillsLab Class

Why CAPA?

CAPA and its purpose
Terms to know: correction, corrective action, and preventive action
Sources of CAPA requirements: FDA, ISO 13485
CAPA guidance
Benefits of CAPA

Exercise! Apply the Terms

Establishing an Effective CAPA Process

Elements of an effective CAPA process
Best practices for managing the CAPA program
Using a risk-based approach to CAPA
CAPA optimization opportunities
Identifying when CAPA is required

Exercise! Map a CAPA Process

Define the Problem

Root cause analysis
A problem-solving culture
Creating problem statements
Common problem definition tools

Exercise! Problem Definition

Refine the Problem

Diagnosing the problem
The problem specification
Data collection and stratification

Exercise! Refining the Problem

Analyze the Root Cause

Root cause investigation process
Fault tree analysis (FTA)

Exercise! Apply the 5 Whys Tool

Exercise! Apply the Fishbone Tool

Verify the Root Cause

Purpose of root cause verification
Testing and verification activities, including logic, trials, and data

Exercise! Verify the Root Cause

Solve the Problem

Selecting the solution
Risk-benefit analysis
Implementing the solution
Verifying the solution
Maintaining the solution

Exercise! Effectiveness Verification

Exercise! Create, Select, and Implement Solutions

Communicate and Document CAPA

Technical writing best practices
CAPA reports
The A3 documentation tool

Exercise! Problem Documentation

Defend the Investigation

FDA inspection of CAPA
Common CAPA issues
Preparing for inspections and audits

What You Will Learn

At the conclusion of this training class, you will be able to

SkillsLab

Identify why CAPA is required and who requires it.

Develop a risk-based approach to the CAPA process to determine the depth of investigation, CAPA cycle time, and any immediate corrections your organization needs to take.

Describe the benefits of creating a problem-solving culture within the organization.

Differentiate and document known problems versus identifying those problems that require further investigation and CAPA.

Create an effective problem statement.

Analyze the root cause: Fishbone, 5 Whys.

Verify the root cause, including with logic, trials, and data.

Select, implement, verify, and maintain solutions.

Document CAPA findings.

Defend the investigation.

Prepare for an FDA inspection of CAPA.

Who Should Attend

Anyone from the medical device, biotech, and pharmaceutical industries participating in root cause analysis investigations or CAPA (Corrective and Preventive Action). Recommended for staff in quality engineering, QA/QC, manufacturing operations, CAPA management, and research and development.

Quality Engineering Personnel
QA/QC Personnel
CAPA Management
Manufacturing Operations Personnel
R&D Personnel

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