Pharmaceutical Manufacturing Training Courses in Australia

Course Description

This course provides an overview of the pharmaceutical industry, including basic information about drug discovery and development, FDA requirements and approval processes, drug dosage forms, and the role of key operational units in drug manufacturing processes. This course enables the students to: understand the role of the pharmaceutical industry in the global market and its implications, learn the fundamentals of the drug development cycle and the investment required to bring a drug to market, learn the most important drug manufacturing processes and the key elements of dosage formulation.

Course Outcome

After completing Pharmaceutical Manufacturing: An Introduction, students will be equipped with a basic understanding of the following:

understand the role of the pharmaceutical industry in the global market and its implications,
learn the fundamentals of the drug development cycle and the investment required to bring a drug to market,
learn the most important drug manufacturing processes and the key elements of dosage formulation.
Recommended Prerequisites

No prior experience or coursework required.

Assessment

Students will be assigned 5 homework assignments, and 1 final exam.

S... [Read More]

The Agile 9.3.1 Material and Equipment Management course teaches students how to work with Agile Recipe and Material Workspace (RMW), the Agile Pharmaceuticals user interface. The course also covers material management processes and equipment management processes. Students will learn how to allocate and dispense material, record material consumption and returns, reserve equipment, and create material and equipment objects.
Learn To: Create Equipment Objects
Order and Receive Material
Allocate and Dispense Material
Pick up, Consume, and Return Material
Reserve Equipment
Create Material Objects

This foundation course, geared toward pharmaceutical and biotechnology professions, is a practical, industry standard, hands-on, case study based approach to managing projects that focuses on the principles of project management. It provides practical examples of project planning concepts of scope, budget, schedule development, risk, quality, and change control. This high impact project management course provides an overview of key project concepts and terminology, and helps individuals effectively initiate, plan, execute, monitor & control, and close a project. It also helps develop and improve project management skills for managing current and future projects and is an ideal course for providing immediate implementation of project management knowledge and skills in your work place.

The course integrates an industry-specific case study, allowing you to see project management theories in practice. Learning topics include:

The NEW Triple constraint
Estimating techniques for task durations
Critical Path Buffer
Crashing and Fast-tracking
Assumptions
and more

Apply lean principles to the process industry of pharmaceuticals. In the pharma industry, the manufacturing plant processes chemicals to create a new product. This is different from an assembly manufacturing process that produces widgets from the assembly of parts.
Lean works. It helps you reduce waste, shorten cycle time, and increase profits. The concepts are the same with some small modifications specific to pharmaceuticals.

Learning Objectives
Understand the difference between traditional "push" and the lean "pull" systems.
Identify the wastes of lean, and see how those wastes reduce your profits, competitive edge, and customer satisfaction.
Recognize how lean directly addresses the elimination/reduction of operating costs, cycle time, and non-value-added activities.
Make better use of employees�time and brainpower in a team environment.
Develop a plan for starting a lean journey in your organization.

This course will introduce students to the modeling and simulation applications in pharmaceutical manufacturing. Learn the basics of discreet event simulation and use commercially available software to develop models of various manufacturing and service systems. Cover approaches to the development conceptual and computer models, data collection and analysis, model verification and validation, and simulation output analysis. Learn how to model chemical, biochemical, and separation processes in pharmaceutical manufacturing using process simulation software. Develop material balances, stream reports, operations and equipment Ghantt charts, conduct process de-bottlenecking, and cost analysis. Required for Master of Engineering Degree.

An introduction to validation concepts in plant, process, clean-up, sterilization, filtration, analytical methods, and computer systems. Learn about Good Automated Manufacturing Practice (GAMP), IEEESQAP, and new electronic requirements, such as 21 CFR Part 11. Explore master validation plans, IQ, OQ, and PQ protocols, and their relationships to GMP. Become familiar with FDA and international (EU) regulations governing current Good Manufacturing Practices (cGMP) and current Good Laboratory Practices (cGLP).

The Stevens Pharmaceutical Manufacturing program is designed to provide students with a solid foundation and thorough understanding of Good Manufacturing Practices in processes, facilities, validation, and project management.

Program Objectives:

Stevens faculty will teach students strategies, methods, and techniques to:

Establish ways to increase quality, reduce costs and speed to market
Maintain compilance with Good Manufacturing Practices
Establish a dependable project control and monitoring system
Enable consistent production and high quality products through a science-based understanding of pharmaceutical materials and manufacturing processes
Prepare students for more managerial responsibilities and higher executive positions


The interdisciplinary program can be customized to address many different job responsibilities within the industry. The primary path is to take virtually all Pharmaceutical Manufacturing (PME) courses, which is appropriate for those who wish to gain broad knowledge of the many facets of the industry together with some in-depth studies of certain technical areas.

One of two degrees can be earned in this program: a Master of Engineering degree or a Master of Science degree. The choice of d... [Read More]

Ideal for project engineers, project managers, and those aspiring to these positions in the parmaceutical industry. Learn about the overall discipline of facilities design, from the introduction to project management concepts & coordination efforts, to the specific implementation concepts for sterile facilities, and finally the latest PAT concepts.

Learn about overall facilities issues, biotechnology processes, specific facilities design concepts, and sterile facilities approaches. Ideal for individuals who work with technical issues within the context of tremenous growth in biopharm facilities.

Detailed exploration of quality programs with specific application to the particular requirements of the pharmaceutical industry. Students will develop an understanding of the quality philosophy which drives the industry from discovery through manufacturing and of the systems and tools that are employed to implement and maintain a sustainable and successful quality system. Application of quality strategies in research and development, commercial production, computer systems, post-marketing, and other areas will be included. Case studies will be used to illustrate the challenges and issues associated with quality system deployment.