International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

The Fundamentals of GCP Corrective and Preventive Actions

Effective CAPA, driven by organizational ownership and thorough effectiveness checks, is not just a regulatory requirement; it is the cornerstone of ensuring ethical and high-quality clinical research, safeguarding both participants and the reliability of trial outcomes. In this course, learners will explore the CAPA process as it relates to Good Clinical Practice through a clinical trial scenario.

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CEU Credits: 0.1
Course Code: ELM-266
Duration: 15 mins
Skill Level: Basic
Language: English
Final Exam: Yes
Certification: Yes
Version: v1.0
Effective Date: 04/15/2025

Curriculum for this course

The RA Treatment Deviation
What Comes Next?
CAPAs Defined
Risks Issues and Process Improvement
Global Regulations
Deviation Severity and CAPAs
Occurrence and Recurrence
Cold CAPA
Deviation and CAPA Process Overview
Return to Sorantics Pharmaceuticals
CAPA Initiation
CAPA Plan
Sorantics Pharmaceuticals CAPA Plan
CAPA Summary & Updates
CAPA Summary & Updates
Effectiveness Checks
Effectiveness Check Update and Closure
Sorantics Pharmaceuticals Effectiveness Checks and CAPA Closure
CAPA & QMS Best Practices
CAPA & The Organization Best Practices
CAPA Definition Best Practices
Conclusion
Test your Knowledge!
v1.0 Course released on 01/27/2026

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