Program Overview

Good Manufacturing Practice: Essentials

Overview

Good Manufacturing Practice: Essentials is an intensive short course that will familiarize participants with the requirements and regulations underpinning Good Manufacturing Practice (GMP) and its application in industry. The short course covers the core principles of GMP, to enable improved understanding of the why, where, and how GMP rules are applied in manufacturing settings. In addition to this fundamental understanding, participants will also learn about the advanced application of GMP in specialized settings.

Program Structure

The program will run over three full-day workshops. There will be approximately 10 hours of online course content which participants will be required to complete before the first workshop.

Who Should Attend

This short course is ideal for those looking to establish or refresh theoretical knowledge and practical skills in the application of GMP within a manufacturing environment. It is suited for entry-level professionals or seasoned professionals involved in biotechnology and pharmaceutical industries, quality control and/or quality assurance managers, manufacturing and production staff, regulatory affairs and compliance specialists, managers or officers, researchers, and healthcare professionals who want to develop a deeper understanding of the core concepts in the field of GMPs and its implementation.

What You Will Learn

• Recognize the principles of Good Manufacturing Practice (GMP) and how they are applied across pharmaceutical manufacturing and inspected by regulators.
• Identify how a pharmaceutical quality system is integrated into manufacturing and where it applies across the supply chain and quality functions.
• Apply GMP documentation principles to ensure compliance with regulatory expectations and maintain accurate, complete, and traceable records.
• Identify sources of contamination and select appropriate behaviors and controls to prevent physical, chemical, and microbiological risks.
• Interpret production processes and controls used in pharmaceutical, sterile, and biological manufacturing to support product quality and compliance.
• Evaluate the role of Quality Control laboratories and apply good documentation and laboratory practices to ensure valid and compliant test outcomes.
• Apply GMP principles and problem-solving skills to real-world scenarios, identifying root causes and corrective actions.
• Apply aseptic practices and behaviors, and contamination controls to maintain sterile manufacturing.

Program Details

• Date: 30th September - 3rd October 2025, 25th November - 28th November 2025
• Time: 8:30am - 5:00pm
• Duration: 10 hours of online content, 2 days of workshops, 1 day laboratory session
• Location: Clayton Campus; Ferntree Gully
• Fees: A$4,995

Instructors

• Steve Williams, Director, Centre for Biopharmaceutical Excellence (CBE)
• Rachel Jensen, Director, Centre for Biopharmaceutical Excellence (CBE)
• Lisa Bennett, Director, Centre for Biopharmaceutical Excellence (CBE)

Digital Badge

Upon completion of the short course, you will be issued with a digital badge. Digital badges demonstrate your capabilities, enhancing your employability and professional profile in today's competitive job market.

Related Programs

• mRNA Manufacturing | Essentials: Gain theoretical expertise and practical experience to enable the implementation of mRNA manufacturing techniques. This short course has been created as a collaboration between the Monash mRNA Workforce Training Centre, Australia and the Centre for Biopharmaceutical Excellence (CBE), Australia.