Complete 12 Modules
Module 1 – Fundamentals of Pharmaceutical Manufacturing Technologies (VOMP 3001)
This module will give you a broad understanding of pharmaceutical manufacturing technologies, the rules that govern manufacturing and the guidelines on how these rules are applied, along with the risk management tools to be used when making decisions that could impact the safety of the medicines being manufactured.
Module 2 – Commissioning & Qualification of Equipment and Systems (VOMP 3002)
This course explains the engineering documentation used to specify and install new equipment systems in a manufacturing facility – and how to develop the test protocols (IQ, OQ, PQ) to ensure that it operates as intended and meets the regulatory requirements.
Module 3 – Chemistry for API’s (VOMP 3003)
The aim of this module is to provide a foundation in the general chemistry necessary to appreciate the fundamental concepts involved in the chemistry of API required for the manufacture of medicinal products.
Module 4 – Pharmaceutical Facility Design (VOMP 3006)
In this module you will receive a strong grounding in the modern pharmaceutical science and engineering concepts of the environmental controls (air) and clean utility systems design that underpin an aseptic manufacturing facility and the quality systems used in this highly regulated environment to ensure the manufacture of safe and effective medicines for the public.
Module 5 – Planning a Validation Strategy (VOMP 3008)
The aim of this module is to teach students how to ensure all user requirements are tested and verified from the beginning and end of a typical project lifecycle, where in the project lifecycle that various testing should occur, and how to make systems functionally and regulatory fit for handover to operations and maintenance.
Module 6 – From URS to PQ – a Validation Project (VOMP 3011)
The aim of these modules is to teach students how to ensure all user requirements are tested and verified from the beginning and end of a typical project lifecycle and where in the project lifecycle that various testing should occur with a view to optimizing resources and minimizing reworks and repeat testing. In addition, you will learn how to make systems functionally and regulatory fit for handover to operations and maintenance.
Module 7 – Mathematics & Statistics for Medicinal Products (VOMP 3004)
This module covers the fundamentals of mathematics and statistics required for method validation. The aim of this module is to provide students with a basis in the fundamentals of mathematics and statistics as applied to method validation.
Module 8 – Physical Chemistry for Industrial Process (VOMP 3009)
This module will provide students with the fundamentals of physical chemistry and enable them to apply them to industrial processing. The material covered will allow students to understand the principles of the topics covered and appreciate the application of these fundamentals to practical problems. In addition the student is introduced to the safety regulations applicable to the workplace and in particular to anywhere where chemicals are used.
Module 9 – Process Development & Technology Transfer (VOMP 3010)
The aim of this module is to give students a broad understanding of clinical, regulatory, and statistical processes involved in the development of new pharmaceutical product applications for drugs, biologicals and medical devices. A further aim is to give students an overview of how to transfer the new drug, bioloigic or device technologies to new and existing facilities.
Module 10 – Design & Operation of Clean Rooms (VOMP 3013)
This module covers the fundamentals of Heating, Ventilation, and Air Conditioning (HVAC) design and how to determine the acceptance criteria for quality of the environment and the frequency of monitoring to minimize the risk of contamination in controlled environments.
Module 11 – Pharmaceutical Manufacturing Unit Operations (VOMP 3015)
Provides you with an understanding of the processing sequence for a pharmaceutical product from beginning to the end of the life cycle and an understanding of facility layouts for commercial scale drug manufacturing.
Module 12 – Aspects of Regulatory Science for Pharmaceutical Manufacturing (VOMP 3019)
This gives a broad understanding of the emerging manufacturing trends, standards and opportunities to ensure the safety, efficacy and performance of a medicinal product in a patient centric environment.
Complete an End of Module Assignment
Each module culminates in the completion of a full assignment, which offers you the opportunity to solidify your knowledge and apply the content in a real world situation.