Good Clinical Practices (cGCP)

Good Clinical Practices (GCP) – Warning Letter Trends

This course is designed to benefit individuals working in a Good Clinical Practice environment who wish to mitigate errors.

At the end of this course, you’ll be able to:

Recall who is most likely to receive Warning Letters and Citations for Good Clinical practices over the last 10+ years
Identify recent GCP inspection reports citations and FDA Warning Letters trends
Given sample FDA Warning Letters, identify examples of GCP compliance

CEU Credits: 0.1

Course Code: ELM-918

Duration: 15 mins

Skill Level: Basic

Language: English

Final Exam: Yes

Certification: Yes

Version: V1.1

Effective Date: 02/10/2023

Curriculum for this course

Course Introduction

Introduction

Who Should Take this Course

What You'll Learn

GCP Overview

GCP Summary

GCP FDA Warning Letters

Trends

Observations

Questions

Data

Case Studies

Knowledge Check

Conclusion

Key Takeaways

What We Covered

Test Your Knowledge

Results

Revision History

Minor update to ensure captions were shown on all slides and to improve quiz functionality

V1.1

Author

Graham O'Keeffe

General Manager - Veeva LearnGxP

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