Process Validation and Regulatory Affairs (Medical Technology) – MSc

This module aims to provide the learner with a knowledge of process engineering management in a manufacturing environment. A learner will be able to evaluate process types, designs, layouts, process analysis, product forecasting, and capacity planning while ascertaining a knowledge of current technologies and automation used in manufacturing.

This module aims to facilitate an in-depth understanding of quality and quality management, from the various definitions of quality to the practical application of systems and processes to manage quality. Learners will be equipped with the knowledge and skills to audit all, or part of, the organisation’s formal Quality Management systems. Learners will develop skills to become leaders and innovators in the application of Quality principles and techniques and develop as quality management professionals for senior roles in the service and manufacturing industry.

Provide learners with an understanding of EU regulatory systems in the pharmaceutical field. The programme will cover the role of regulatory affairs, classification, regulatory structure, recent and forecasted changes, and the impact of various submission pathways as they apply to pharmaceuticals in the EU market. This module will explore theory, regulations, tools and techniques used in these companies. As well as giving learners competence in the appropriate legal, compliance and operational standards in industry. This module will enhance a learner’s career in regulatory affairs by increasing competence and professionalism and obtaining a formal qualification in the pharmaceutical regulation industry.

This module aims to develop learners’ research skills and ability to work independently to produce a dissertation in accordance with pre-determined formats, standards and ethics. The selected topic must be directly relevant to the course of study undertaken by the student. The dissertation is to provide an exhaustive, critical and in-depth analytical analysis of the specific area of interest. The dissertation may be research-based, carried out in collaboration with industry or a combination of methodologies.

Learners will gain an in-depth understanding of the application of Risk Management within organisational Quality Management Systems. Learners will acquire the ability to objectively evaluate evidence generated by systems and processes against clearly defined criteria and determine the effectiveness of these systems and processes. There will also be a focus on managing external audits by second and third parties (customers and regulators/notified bodies). Learners will develop skills to become leaders and innovators in the application of Quality principles and techniques and develop as quality management professionals for senior roles in the service and manufacturing industry.

Provide the learner with an overview of process and product validation in manufacturing environments. The focus will be on Process validation with emphasis on the tools and techniques used in the operations and manufacturing environment, ensuring that operations are efficient in terms of using as few resources as needed, compliance with regulatory requirements and effective in terms of meeting customer requirements.

This module aims to develop learners’ research skills and ability to work independently to produce a dissertation in accordance with pre-determined formats, standards and ethics. The selected topic must be directly relevant to the course of study undertaken by the student. The dissertation is to provide an exhaustive, critical and in-depth analytical analysis of the specific area of interest. The dissertation may be research-based, carried out in collaboration with industry or a combination of methodologies.