Process Validation and Regulatory Affairs (Medical Technology) - MSc

Program Overview

Process Validation and Regulatory Affairs (Medical Technology) – MSc

Course Overview

Many companies operate in highly regulated areas where the demand for dynamic validation engineers, effective quality management systems and regulatory compliance leaders is growing in the Medical Technology industry. The aim of the Level 9 Taught Masters of Science in Process Validation and Regulatory Affairs is to equip learners with competence in the appropriate legal, compliance and industry operational standards. The programme will enable an understanding of all current applicable regulations, quality management systems and effective process validation requirements. Learners will have the knowledge and skills to audit all, or part of, the organisation’s formal Quality Management systems. 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; ensuring that learners will develop skills to address and prepare for the ever-changing environment of regulatory affairs in the Medical Technology sector.

Critical thinking, problem solving, decision making, professionalism and management techniques will be key areas covered by the programme.

Entry Requirements

• A minimum honours bachelor degree (Level 8) in any discipline with minimum, relevant work experience and/or ability, evidenced by an RPL portfolio of prior experience and learning.
• A minimum ordinary bachelor degree (Level 7) in any discipline with minimum two years relevant work experience and/or ability, evidenced by an RPL portfolio of prior experience and learning.
• Equivalent Qualifications. Applicants with equivalent qualifications on the European and International frameworks will also be considered. International students must evidence a proficiency in English language for example IELTS 6.5.

Course Modules

Semester 1 – September to December

• Advanced Process Management
  • Credits: 10
  • 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.
• Quality Management
  • Credits: 10
  • 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.
• Regulatory Affairs (Medical)
  • Credits: 10
  • 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.
• Dissertation (Yearlong)
  • Credits: 30
  • 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.

Semester 2 – January to May

• Advanced Regulatory Affairs (Medical)
  • Credits: 10
  • Understanding of the utilisation of standards, America and other jurisdictions’ guidance documents and technical writing. The module 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 world market.
• Auditing and Risk Management
  • Credits: 10
  • 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
    otified 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.
• Process Validation
  • Credits: 10
  • 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.
• Dissertation (Yearlong)
  • Credits: 30
  • 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.

Career Opportunities

This programme has been designed to meet the growing requirements of pharmaceutical companies in filling Quality, Validation, Management, Auditing, Compliance, Legal and Regulatory affairs. The motivation for developing this programme emerged from industry needs, gaps in education programmes and a lack of graduates in the hiring pool. The content has been developed jointly by TUS in conjunction with industry consultants and industry practitioners from companies such as Abbott, BD Medical, Johnson & Johnson, Regeneron, Edward Science, Boston Scientific etc.

There are multiple roles a graduate from the programme can seek in disciplines such as Validation, Management, Auditing, Compliance, Legal and Regulatory affairs.

• Regulatory Affairs Specialist / Engineer / Manager
• Verification and Validation Specialist / Engineer /Manager
• Quality and auditing Specialist / Engineer / Manager
• Compliance Specialist / Engineer / Manager
• Verification and Validation Specialist / Engineer /Manager
• Manufacturing or Process Engineer/ Manager

Further Study

Upon successful completion of this programme, graduates have the opportunity to complete Level 9/10 programmes here at TUS or elsewhere.

Program Outline

Degree Overview:

The MSc in Process Validation and Regulatory Affairs (Medical Technology) is a Level 9 Taught Masters program designed to equip learners with the knowledge and skills needed to excel in the highly regulated Medical Technology industry. The program aims to provide learners with competence in legal, compliance, and industry operational standards, ensuring they understand current regulations, quality management systems, and effective process validation requirements. The program focuses on developing critical thinking, problem-solving, decision-making, professionalism, and management techniques. Graduates will be able to audit Quality Management systems, objectively evaluate evidence, and effectively address the ever-changing regulatory landscape in the Medical Technology sector.

Outline:

The program is structured over two semesters, with modules running from September to December (Semester 1) and January to May (Semester 2).

Semester 1:

• Advanced Process Management (Credits: 10): This module provides learners with a comprehensive understanding of process engineering management in a manufacturing environment.
It covers topics such as process types, designs, layouts, process analysis, product forecasting, capacity planning, and current technologies and automation used in manufacturing.
• Quality Management (Credits: 10): This module delves into the intricacies of quality and quality management, encompassing various definitions of quality and the practical application of systems and processes to manage quality.
Learners will gain the knowledge and skills to audit Quality Management systems, develop leadership and innovation in quality principles and techniques, and prepare for senior roles in the service and manufacturing industry.
• Regulatory Affairs (Medical) (Credits: 10): This module provides learners with a thorough understanding of EU regulatory systems in the pharmaceutical field.
It covers 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. The module explores theory, regulations, tools, and techniques used in the industry, equipping learners with competence in legal, compliance, and operational standards.
• Dissertation (Yearlong) (Credits: 30): This module focuses on developing learners' research skills and independent work abilities.
Students will conduct a dissertation in accordance with pre-determined formats, standards, and ethics. The dissertation topic must be directly relevant to the course of study and should provide an exhaustive, critical, and in-depth analytical analysis of the chosen area of interest. The dissertation can be research-based, carried out in collaboration with industry, or a combination of methodologies.

Semester 2:

• Advanced Regulatory Affairs (Medical) (Credits: 10): This module builds upon the foundation laid in Semester 1, focusing on the utilization of standards, guidance documents from America and other jurisdictions, and technical writing.
It covers 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 global market.
• Auditing and Risk Management (Credits: 10): This module provides learners with an in-depth understanding of Risk Management within organizational 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. The module also focuses on managing external audits by second and third parties (customers and regulators
otified bodies). Learners will develop skills to become leaders and innovators in the application of Quality principles and techniques and prepare for senior roles in the service and manufacturing industry.
• Process Validation (Credits: 10): This module provides learners with an overview of process and product validation in manufacturing environments.
The focus is on Process validation, emphasizing the tools and techniques used in the operations and manufacturing environment, ensuring efficient operations, compliance with regulatory requirements, and meeting customer requirements. However, it is stated that the content has been developed jointly by TUS in conjunction with industry consultants and industry practitioners from companies such as Abbott, BD Medical, Johnson & Johnson, Regeneron, Edward Science, and Boston Scientific. This suggests a practical and industry-focused approach to teaching.

Careers:

The program is designed to meet the growing requirements of pharmaceutical companies in filling Quality, Validation, Management, Auditing, Compliance, Legal, and Regulatory affairs roles.

Career Opportunities Include:

• Regulatory Affairs Specialist / Engineer / Manager
• Verification and Validation Specialist / Engineer /Manager
• Quality and auditing Specialist / Engineer / Manager
• Compliance Specialist / Engineer / Manager
• Verification and Validation Specialist / Engineer /Manager
• Manufacturing or Process Engineer/ Manager

Further Study:

Upon successful completion of the program, graduates have the opportunity to pursue Level 9/10 programs at TUS or other institutions.

Other:

The program is specifically designed to address industry needs, gaps in education programs, and a lack of graduates in the hiring pool.