Good Manufacturing Practices (cGMP) - Advanced

21 CFR Part 211 Subpart B: Organization and Personnel

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

CEU Credits: 0.1

Course Code: ELM-211

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

Responsibilities of the Quality Control Unit (Sect. 211.22)

Drug Product Approval, Rejection, and Records Review

Adequacy of Laboratory Facilities

Approval and Rejection of Procedures and Specifications

Personnel Qualifications (Sect. 211.25)

Job and cGMP Training

Qualifications for Supervisory Roles

Number of Qualified Personnel

Personnel Responsibilities (Sect. 211.28)

Clothing and PPE

Sanitation and Authorized Access

Illness and Injury

Consultants (Sect. 211.34)

Consultants (Sect. 211.34)

Conclusion

Final Assessment

Certification

Author

Graham O'Keeffe

General Manager - Veeva LearnGxP

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