Good Manufacturing Practices (cGMP) - Advanced

21 CFR Part 211 Subpart J – Records and Reports

This course focuses on providing an understanding of the U.S. Food and Drug Administration’s current Good Manufacturing Practices (cGMP) regulations on Records and Reports 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-210

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. 211.180)

Required Length of Time to Retain Records (a)(b)

Availability of Records and Reports (c)(d)

Written Records and Procedures for Annual Evaluation (e)(1)(2)

Notification of Responsible Parties (f)

Module 2: Equipment Cleaning and Use Log (Sect. 211.182)

Equipment Cleaning and Use Log (Sect. 211.182)

Module 3: Component, Drug Product Container, Closure, and Labeling Records (Sect. 211.184)

Component, Drug Product Container, Closure, and Labeling Records (Sect. 211.184)(a)(b)(c)(d)(e)

Module 4: Master Production and Control Records (Sect. 211.186)(a)

Master Production and Control Records Requirements (b)(1-9)

Module 5: Batch Production and Control Records (Sect. 211.188)(a)(b)(1-13)

Batch Production and Control Records (Sect. 211.188)(a)(b)(1-13)

Module 6: Production Record Review (Sect. 211.192)

Production Record Review (Sect. 211.192)

Module 7: Laboratory Records (Sect. 211.194)(a)(1-8)

Laboratory Records: Additional Requirements (b)(c)(d)(e)

Module 8: Distribution Records (Sect. 211.196)

Distribution Records (Sect. 211.196)

Module 9: Complaint Files (Sect. 211.198)

Written Procedures (a)

Complaint File Creation and Maintenance (b)

Written Record (1)(2)(3)

Conclusion

Final Assessment

Certification

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