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Medical Devices CAPA

Overview

Course Description

This course is intended to provide students with the elements of a corrective and preventive action (CAPA) system, taken to eliminate causes of non-conformities or other undesirable situations.

This course is broken down into three modules. The first module identifies the primary elements and sequence of activities for conducting a CAPA. The second module explains how to define a problem statement and conduct the root cause investigations, tools that can help you in effectively investigating problems. The third module explains how to implement and effectively close out a CAPA.

At The End Of The Course You Will Be Able To

  • Understand FDA’s and other regulatory officials’ expectations for “what CAPA is” and the steps required to get you there.
  • Know how to improve your CAPA process, from CAPA sources and preventive actions through root cause analysis, action plans and effectiveness check.
  • Understand the main elements and sequence of activities for conducting a CAPA.
  • Understand how to define a problem statement, the conducting of root cause investigations, tools that can aid you in effectively investigating problems.
  • Recognize how to close the CAPA loop and the requirements to close CAPAs in a timely and complete manner.
  •  Understand how to establish a compliant Corrective Action and Preventive Action (CAPA).

Course Content

  1.  Module 1. Initiate – Investigation Plan – Correction/Containment
    • Introduction to CAPA
    • Initiation
    • Investigation
    • Plan
    • Containment / Correction
  2. Module 2. Investigation, Root Cause Analysis – Solution V&V
    • Root Cause Analysis
    • Solution V&&
  3. Module 3. Implementation-VoE-Closure
    • Implementation
    • VoE
    • Closure

Description

Learn the tools and practical experience to correctly define problems, identify root causes and implement solutions.

Duration: 12 hours

Modality: Group

Participant limit: 15

Download Course Technical Information

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Course Features

Learn the tools and practical experience to correctly define problems, identify root causes and implement solutions.

Duration: 12 hours

Modality: Group

Participant limit: 15

Download Course Technical Information

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