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Updated in [July 27th, 2023]

This course provides learners with an in-depth understanding of the Quality Management System (QMS) in the pharmaceutical industry. Learners will gain an understanding of the three levels of quality, the role of management in the QMS, the objectives of the QMS, and how the elements of the QMS are integrated. Additionally, learners will gain an understanding of the meaning and application of the QMS in the pharmaceutical industry, the quality standards and pharmacopeias behind it, the ISO, GMP, and GXP, and the importance of documentation. Finally, learners will gain an understanding of personnel training and process validation.

Course Syllabus

Introduction

QMS Objectives

Fundamentals of GMP

Quality Standards

ISO 9001

GMP

GXP

GDP

GMP Training

Process Validation

Risks