Good Manufacturing Practices (cGMP) - Advanced

21 CFR Part 211 Subpart H – Holding and Distribution

This course focuses on providing an understanding of the U.S. Food and Drug Administration’s current Good Manufacturing Practices (cGMP) regulations on holding and distribution of drug products. These regulations are outlined in 21 Code of Federal Regulations (CFR) Part 211. The purpose of this course is to present the regulations in a clear and concise manner in order to provide participants with the necessary information required to maintain the safety and efficacy of drug products.

CEU Credits: 0.1

Course Code: ELM-207

Duration: 30 mins

Skill Level: Intermediate

Language: English

Final Exam: Yes

Certification: Yes

Version: V1.0

Curriculum for this course

Introduction

Overview

Who Should Take This Course?

Learning Objectives

Definitions

Drug Warehousing and Distribution

Warehousing Procedures (Sect. 211.142)(a)(b)

Distribution Procedures (Sect. 211.150)(a)(b)

What is a Product Recall?

Recalls: Over-the-Counter vs. Prescription Drugs

Voluntary vs. Involuntary Recalls

Conclusion

Final Assessment

Certification

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