Good Manufacturing Practices (cGMP) - Advanced

21 CFR Part 211 Subpart E – Control of Components, Drug Product Containers and Closures

This course focuses on providing an understanding of the U.S. Food and Drug Administration’s current Good Manufacturing Practices (cGMP) regulations on Control of Components and Drug Product Containers and Closures for drug manufacturing, processing, packing, or holding. 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.

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CEU Credits: 0.1

Course Code: ELM-206

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

Module 1: General Requirements (Sect. 211.80) (a)(b)(c)(d)

General Requirements (Sect. 211.80) (a)(b)(c)(d)

Module 2: Receipt and Storage of Untested Components, Drug Product Containers, and Closures (Sect. 211.82) (a)(b)

Receipt and Storage of Untested Components, Drug Product Containers, and Closures (Sect. 211.82) (a)(b)

Module 3: Testing and Approval or Rejection of Components, Drug Product Containers, and Closures (Sect. 211.84)

General Instructions (a)(b)

Sample Collection Procedure (c)(1-6)

Sample Testing Procedure (d)(1-6)

Approval or Rejection (e)

Module 4: Use of Approved Components, Drug Product Containers, and Closures (Sect. 211.86)

Use of Approved Components, Drug Product Containers, and Closures (Sect. 211.86)

Module 5: Retesting of Approved Components, Drug Product Containers, and Closures (Sect. 211.87)

Retesting of Approved Components, Drug Product Containers, and Closures (Sect. 211.87)

Module 6: Rejected Components, Drug Product Containers, and Closures (Sect. 211.89)

Rejected Components, Drug Product Containers, and Closures (Sect. 211.89)

Module 7: Overview: Drug Product Containers and Closures (Sect. 211.94)

Drug Product Containers and Closures (a)(b)(c)(d)

Medical Gas Containers and Closures (e)

Gas-Specific Use Outlet Connections (1)

Label and Coloring Requirements (2)

Conclusion

Final Assessment

Certification

Author

Graham O'Keeffe

General Manager - Veeva LearnGxP

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