Good Manufacturing Practices (cGMP) - Advanced

21 CFR Part 211 Subpart D – Equipment

This course focuses on providing an understanding of the U.S. Food and Drug Administration’s current Good Manufacturing Practices (cGMP) regulations for equipment used for drug manufacturing and related processes. These regulations are outlined in 21 Code of Federal Regulations (CFR) Part 211. A link to these regulations on the FDA’s website is available in the Resources tab of this course. 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-212

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

Equipment Design, Size, and Location (Sect. 211.63)

Equipment Design, Size, and Location

Equipment Construction (Sect. 211.65)

Materials Used for Construction

Substances Required for Operation

Equipment Cleaning and Maintenance (Sect. 211.67)

Cleaning and Sterilization

Written Procedures

Recordkeeping

Automatic, Mechanical, and Electronic Equipment (Sect. 211.68)

Calibration and Inspection

Computer System Controls and Validation

Checking Performance of Automated Equipment

Filters (Sect. 211.72)

Filters

Conclusion

Final Assessment

Certification

Author

Graham O'Keeffe

General Manager - Veeva LearnGxP

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