Annual Refresher Training

Annual GxP Refresher Training (2023)

This course is designed to help you understand trends in observation in the life sciences industry. By understanding the trends in observations written during regulatory inspections, you will be better prepared to help your organization strive for GxP compliance at every turn. Because regulatory trends shift focus every year based on the direction of the industry, this course is intended to review 2022 warning letter trends.

Unique Features:

Aligned with 2022 requirements and warning letters, based on recent and relevant information
Different learning paths within the course based on work function
Customized final assessment – includes two general GxP questions, and three questions based on the path chosen by the learner
And so much more!

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CEU Credits: 0.1

Course Code: ELM-931

Duration: 15 mins

Skill Level: Basic

Language: English

Final Exam: Yes

Certification: Yes

Version: V1.3

Effective Date: 04/25/2023

Curriculum for this course

Welcome

Course Introduction

What You'll Learn

GxP Review

What are GxP Requirements?

How GxP Aplies to Everyone

Why are Regulatory Inspections So Important?

Choose a GxP Scenario

Good Manufacturing Practice - GMP

GMP Review

GMP Refresher

Real Life Example

GMP Scenario

Let's Continue

Finishing Your Work

Resolution

GMP Scenario Recap

Good Laboratory Practice - GLP

GLP Review

GLP Refresher

Real Life Example

GLP Scenario

Let's Continue

Finishing Your Work

Resolution

GLP Scenario Recap

Good Clinical Practice - GCP

GCP Review

GCP Refresher

Real Life Example

GCP Scenario

Let's Continue

Finishing Your Work

Resolution

GCP Scenario Recap

Good Pharmacovigilance Practice - GVP

GVP Review

GVP Refresher

Real Life Example

GVP Scenario

Let's Continue

Finishing Your Work

Resolution

GVP Scenario Recap

Conclusion

What We Covered

Test Your Knowledge

Revision History

v1.3 Minor update on 04/03/2025. Course template enhanced to provide more specific quiz completion data and a Version History document. Course content has not been changed.

v1.2 Minor update on 08/10/2023 to clarify information in the GLP section

v1.1 Minor update on 07/26/2023 to include a GxP function-specific certificate of completion

v1.0 Course released on 06/26/2023