Good Manufacturing Practices (cGMP) - Advanced

21 CFR Part 211 Subpart K – Returned and Salvaged Drug Products

This course focuses on providing an understanding of the U.S. Food and Drug Administration’s current Good Manufacturing Practices (cGMP) regulations on returned and salvaged drug products. These regulations are outlined in 21 Code of Federal Regulations (CFR) Part 211.

CEU Credits: 0.1

Course Code: ELM-213

Duration: 45 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

Returned and Salvaged Drug Products (Sect. 211.204)

Returned and Salvaged Drug Products

Returned Drug Products

Identification and Holding of Returned Drug Products

Reprocessing of Returned Drug Products

Recordkeeping and Investigation of Returned Drug Products

Drug Product Salvaging (Sect. 211.208)

Drug Salvaging Basics

Handling Questionable Conditions of Salvaging

FDA Guidance on Drug Salvaging

Improper Storage Conditions: Natural Disasters

Improper Storage Conditions: Toxic Fumes and Radiation

Considerations for Assessing Radioactive Material Contamination

Conclusion

Final Assessment

Certification

Author

Graham O'Keeffe

General Manager - Veeva LearnGxP

Courses

Browse our extensive catalog of GxP, Corporate Compliance and EH&S training.

Learning Strategy

Boost your organization’s training with LearnGxP’s Learning Strategy Consultants (LSC). They customize learning paths to match your needs, offering ongoing support for lasting success.

Customer Stories

Discover how LearnGxP addresses real challenges, provides effective solutions, and positively impacts our customers’ organizations.