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: V3.0
Effective Date: 08/01/2024

Curriculum for this course

Course Introduction
What is a CAPA?
CAPA Goals and Objectives
Sources of CAPAs
Identifying CAPAs
CAPA Considerations
Writing CAPAs
Planning to Implement CAPAs
Measurable and Verifiable
Considering New Risks
Retraining as a Corrective Action
Product X Deviation CAPA Example
Designing Effectiveness Checks
Effectiveness Checks Additional Details
Writing Executive Summaries
Executive Summary Example
Summary
Test Your Knowledge
This course has been redesigned. The redesign includes new learning objectives to align with updated content, as well as a new exam for those objectives. The visual design has been updated as well.
V3.0
Updates to fix course functionality
V2.1
Redesigned course with new Articulate Storyline player
V2.0
Added new Review Activities
V2.0
Added new final exam question to align with learning objectives
V2.0
Updated Glossary links
V2.0

Author

Matt Peplowski

Owner & Principal, Biopharm Error Prevention Associates, Inc.

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