Good Manufacturing Practices (cGMP) - Advanced

21 CFR Part 211 Subpart F: Production and Process Controls

This course focuses on providing an understanding of the U.S. Food and Drug Administration’s current Good Manufacturing Practices (cGMP) regulations on production and process controls for drug manufacturing, processing, packing, or holding. 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-208

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: Written Procedures and Deviations (Sect. 211.100)(a)(b)

Written Procedures and Deviations (Sect. 211.100)(a)(b)

Module 2: Charge-In of Components (Sect. 211.101)

Preserving the Active Ingredient (a)

Removal of Components from the Original Container (b)(1-4)

Supervision and Secondary Examination (c)(1-3)

Verifying the Batch (d)

Module 3: Calculation of Yield (Sect. 211.103)

Key Terms

Determining Actual Yields and Percentages

Module 4: Equipment Identification (Sect. 211.105)

Equipment Identification (Sect. 211.105)(a)(b)

Module 5: Sampling and Testing of In-Process Materials and Drug Products (Sect. 211.110)

Key Terms

Written Procedures (a)(1-6)

Specifications (b)

In-Process Materials (c)(d)

Module 6: Time Limitations on Production (Sect. 211.111)

Time Limitations on Production (Sect. 211.111)

Module 7: Control of Microbiological Contamination (Sect. 211.113)(a)(b)

Control of Microbiological Contamination (Sect. 211.113)(a)(b)

Module 8: Reprocessing (Sect. 211.115)(a)(b)

Reprocessing (Sect. 211.115)(a)(b)

Conclusion

Final Assessment

Certification

Author

Graham O'Keeffe

General Manager - Veeva LearnGxP

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