COURSE CURRICULUM

The MSc in Process Validation and Regulatory Affairs (Pharmaceutical) is a Level 9 program designed to develop advanced expertise in pharmaceutical manufacturing, quality systems, regulatory compliance, and process validation. In Semester 1, students study Advanced Process Management, which covers manufacturing systems, process design, automation, forecasting, and capacity planning within industrial environments. Quality Management develops a deep understanding of quality principles and equips learners with the ability to audit and improve formal quality management systems, preparing them for leadership roles in the industry. Regulatory Affairs (Pharmaceutical) focuses on EU pharmaceutical regulations, classification systems, submission pathways, and compliance requirements, ensuring learners gain competence in legal and operational standards within the sector. A year-long Dissertation begins in this semester, requiring independent research aligned with pharmaceutical industry topics. In Semester 2, Advanced Regulatory Affairs expands knowledge of global regulatory frameworks, including international standards, technical writing, and regulatory changes across jurisdictions. Auditing and Risk Management focuses on risk assessment, compliance evaluation, and managing external audits within quality systems. Process Validation provides practical understanding of validating manufacturing processes to ensure efficiency, compliance, and product quality. The Dissertation continues throughout the program and concludes with a substantial research project. Overall, the program prepares graduates for senior roles in regulatory affairs, validation, auditing, and quality management in the pharmaceutical industry.