Master of Good Manufacturing Practice

Program Overview

The Master of Good Manufacturing Practice equips students with comprehensive knowledge and skills in GMP principles and practices for the pharmaceutical, biotechnology, and medical device industries. The program prepares graduates for careers in quality assurance, compliance, and management roles, including Production Manager, Quality Assurance Manager, and Regulatory Affairs Manager. This unique program in the Asia-Pacific region provides a solid foundation for career advancement in the heavily regulated healthcare industry.

Program Outline

Degree Overview:

Overview:

The Master of Good Manufacturing Practice provides up-to-date and in-depth good manufacturing practice (GMP) knowledge within the pharmaceutical, biotechnology, and medical device industries. The course provides critical knowledge of legislation relating to the registration, manufacture, storage, and supply of licenced therapeutic goods; GxP and quality systems compliance; and the concepts of quality management, risk management, aseptic practices, supply chain, clinical trials, quality assurance, and quality control within this heavily regulated industry – all essential ingredients for career development. This is the only course of its kind in the Asia–Pacific region.

Objectives:

The objectives of the Master of Good Manufacturing Practice are:

• To provide students with a comprehensive understanding of the principles and practices of Good Manufacturing Practice (GMP) as applied to the pharmaceutical, biotechnology, and medical device industries.
• To equip students with the skills and knowledge necessary to develop, implement, and manage GMP systems within these industries.
• To prepare students for careers in the pharmaceutical, biotechnology, and medical device industries, with a focus on GMP compliance and quality assurance.

Program Description:

The Master of Good Manufacturing Practice is a two-year full-time or four-year part-time program that consists of coursework and a research project. The coursework component of the program includes the following core subjects:

• GMP for Manufacturing Operations
• Validation Principles and Practices
• International GMPs and Quality Assurance
• Good (Quality Control) Laboratory Practices
• Contamination Control
• Good Aseptic Practices and Sterile Products
• GxP and Quality Auditing Practices
• Risk Management for Pharmaceutical Operations
• Process Development for Therapeutics: A Perspective for Finished Dose Forms
• Clinical Trials Quality Assurance Management
• Supply Chain Management
• Computer Systems Validation Principles and Practices

Careers:

Career Options:

Career options include:

• Production Manager/ Supervisor
• Quality Assurance Manager/ Associate
• Industrial Pharmacist
• Quality Control Manager
• Documentation Manager
• Validation Manager
• Supply Chain Manager
• Regulatory Affairs Manager/Associate in the pharmaceutical, biotechnology, medical device, and allied industry.
• Auditor in government regulatory agencies
• Consultant in consulting firms and
• Managers and practitioners in various other associated companies where good manufacturing practices are required.