Good Documentation Practices (GDocP)

CAPA and Effectiveness Checks

This course is designed to equip you with the essential knowledge and skills to effectively manage and resolve quality issues within your organization. You will learn about the critical role of Corrective and Preventive Actions (CAPAs) in maintaining product quality and compliance.

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CEU Credits: 0.1

Course Code: ELM-117

Duration: 20 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Certification: Yes

Version: V3.1

Effective Date: 08/01/2024

Curriculum for this course

Welcome

Course Introduction

CAPA Overview

What is a CAPA?

CAPA Goals and Objectives

Sources of CAPAs

Identifying CAPAs

CAPA Considerations

Writing CAPAs

Planning to Implement CAPAs

CAPA Best Practices

Measurable and Verifiable

Considering New Risks

Retraining as a Corrective Action

Product X Deviation CAPA Example

Effectiveness Checks

Designing Effectiveness Checks

Effectiveness Checks Additional Details

Executive Summaries

Writing Executive Summaries

Executive Summary Example

Conclusion

Summary

Test Your Knowledge

Revision History

v3.1 Minor update on 02/11/2025 Course template enhanced to provide more specific quiz completion data and a Version History document. Course content has not been changed.

v3.0 Major update on 08/01/2024. This course has been redesigned. The redesign includes new learning objectives to align with update content, as well as a new exam for those objectives. The visual design has been update as well.

v2.1 Minor update on 05/04/2023 to improve course functionality.

v1.0 Course released in 2021