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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

Course Code Location Class Begins Class Ends Daily Schedule Course Delivery Class Agenda Registration
CRF VIRTUAL DELIVERY (Eastern time - PM) 12 Aug 2024 16 Aug 2024 1:00PM - 5:00PM Eastern US Time Virtual REGISTER
CRF VIRTUAL DELIVERY (Eastern time - PM) 04 Nov 2024 08 Nov 2024 1:00PM - 5:00PM Eastern US Time Virtual 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

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

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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