This module is designed to support students in the personal development of professional skills in the workplace through engaging in enriching workplace-based learning activities. Students will gain experience of a variety of workplace-based activities in an environment relevant to the programme and reflect on their role and evolving skill base in a workplace-based context. Throughout the module, students will maintain a structured reflective journal/portfolio, logging activities and demonstrating personal reflection and development, and at the end of the module provide a concise report and presentation summarizing aspects of their reflective experiences and key learnings.

1. Develop professional skills including written communication skills, presentation, interview, time management, project management, and conflict resolution skills.

2. Reflect on the mission/vision, aims/objectives, and structure of the organization and conduct SWOT analysis of a defined workplace function/structure, methodology, practice, or policy, and also a personal SWOT analysis.

3. Detail how a clearly defined workplace methodology, practice, or policy they have personally used could be applied in another context with the industry sector.

4. Demonstrate advancement in personal effectiveness in the workplace with indicators of having undertaken appropriate continuing professional development (CPD).

5. Reflect on performance enhancement and demonstrate ability to undertake self-appraisal.

This module is designed to support students acquiring knowledge and understanding of the academia/industry research environment and methods of dissemination and communication including core aspects of commonly employed qualitative and quantitative research methods; review and analysis of research reports, literature and data; project design, planning, and implementation; data acquisition and analysis; plus accurate and appropriate dissemination/reporting, and communication of outcomes.

1. Describe relevant research processes, evidencing ability to differentiate and distinguish between appropriate application of qualitative and quantitative methodologies.

2. Summarise, integrate, compare, and show evidence of critical analysis of relevant literature through generation of a literature review on a relevant topic.

3. Identify appropriate methodologies for investigation of a question and articulate key components of an undergraduate project through development of a concise project proposal and more detailed plan of investigation.

4. Recognise academic integrity including rules and regulations governing research, innovation, and ethics as it relates to academia/industry, demonstrating an appreciation of core aspects of intellectual property, the research landscape, and how research is supported and funded.

This module aims to provide students with a detailed knowledge and understanding of the general principles and methods of Biocontamination control; establishing and verifying the formal system for contamination control and associated test methods and requirements; traditional and modern methods of microbial detection; expressing, interpreting and reporting results; training and documentation requirements.

1. Discuss and critically evaluate the most relevant microbes for the biopharmaceutical industry and identify and discuss appropriate prevention techniques for each contaminant.

2. Source and interpret the theory behind the detection test methods available, including traditional and rapid identification testing.

3. Develop and justify an appropriate monitoring regime for a pharmaceutical/biopharmaceutical facility.
4. Describe the relevant regulatory expectations for Biocontamination Control including ICH Q8, Q9 and Q10.
5. Perform research on a relevant topic and analyse, evaluate, communicate and explain scientific data relating to biocontamination control.

This module introduces the regulatory requirement for GMP & compliance auditing, its benefits to an organisation and the tools required by an effective auditor. In addition, it also introduces corrective and preventive action, non conformance reporting and ongoing compliance.

1. Interpret and explain the relevance of auditing as a means of monitoring the production of safe and effective medtech products in a GMP environment.
2. Describe the various auditing techniques available and the regulatory basis for GMP/compliance auditing
3. Source, interpret and apply GMP principles to different case scenarios
4. Role play in a multidisciplinary team of auditors within a GMP environment
5. Critique the performance of a systematic and independent examination of the effectiveness of a quality system
6. Identify, assess and analyse breaches of GMP and recommend appropriate corrective and preventive actions
7. Evaluate non conformance statements and understand the non conformance management process

This module aims to provide students with an introduction to current and future knowledge of strategic operations including Industry 4.0, MedTech 4.0, and Smart Operations engineering and management in the context of a GMP environment.

1. DebateManufacturing & Operations Engineering functions and the importance of Operations Engineering Strategy in Product and Service design, Process Technology and Quality Control.

2. Recognise and Define GMP, Manufacturing types and layouts and describe how to balance a line
3. Explain Purchasing, Logistics, and Supply Chain Management concepts as well as Planning and Inventory control in the context of a GMP organization.

4. Explain Industry 4.0 in the context of MedTech 4.0; definition, technologies, various Operations strategies in the context of a GMP organisation.

5. Summarise and explainOperational Excellence; Lean philosophy, Six Sigma;AgileProject Planning in the context of GMP Operations Management.

6. Illustratedata analytics; tools and techniques and calculations to demonstrate understanding and application of the learning outcomes.

This module is designed to support student's personal development of professional skills in the workplace including the student's ability to independently apply the knowledge, skills, and competences they have acquired in the course, in the completion of a substantive Level 8 project. Through engaging in an enriching workplace-based project, students will expand their work practice knowledge, skills, and competencies relevant to the programme and workplace, reflected in their coursework and assessment.

1. Independently plan and manage activities to deliver a quality project according to agreed deadlines with minimum supervision.

2. Interpret data and/or literature findings in relation to a defined project-related question, objective, or hypothesis.

3. Communicate project outcomes displaying competent scholarly/technical writing and referencing according to standard conventions.

4. Deliver a structured presentation on the project and key outcomes in the appropriate format and provide a defence of the project and key future directions of the work.

5. Relate project work undertaken to ongoing work of the company and industry more generally and discuss the contribution/impact of the project in the context of company objectives.

6. Articulate how the project has contributed to personal and professional development and skills enhancement.

7. Reflect on performance enhancement and demonstrate ability to undertake self-appraisal and identify and partake in professional/career development activities.

This module aims to provide the student with a good understanding of the main support service areas involving both facilities and utilities that underpin the modern biopharmaceutical manufacturing industry.

1. Outline the main elements and features of facilities and utilities relating to the modern biopharmaceutical industry.
2. List and describe the main facility design concepts including cleanroom technology for Biopharmaceutical Processing.
3. Describe the key elements of a water treatment system for Biopharmaceutical Processing.
4. Describe the key principles involved in cleaning and sterilisation systems for Biopharmaceutical Processing.
5. Understand the application of minor equipment and design and testing principle of piping systems within a Bioprocessing Facility.

6. Perform research on a relevant topic and analyse, evaluate and draw conclusions accordingly. Communicate and explain scientific data relating to facilities and utilities for biopharmaceutical processing.

This module aims to provide students with a detailed knowledge and understanding of the various analytical assays routinely employed in the analysis of critical quality attributes (CQAs) of biopharmaceuticals. These analytical assays are used to assess the raw material, in-process, bulk drug substance and finished product quality attributes.

1. Outline and evaluate the various assays/tests methods and instrumentation routinely employed in the analysis of Biopharmaceuticals.
2. Formulate and communicate judgements with regard to the complexities and challenges in the analysis of biologics.
3. Analyse, evaluate and draw conclusions from data presented in problem solving exercises.
4. Perform research on a relevant topic and analyse, evaluate and draw conclusions accordingly.
5. Communicate and explain scientific data relating to bioanalytics.

This module introduces the regulatory requirement for calibration and validation within a GMP environment, their benefits to an organisation and the tools required for effective implementation This module will prepare students to undertake different validation roles and will equip the student to complete many validation activities within their organisation. The impetus for the development of this module has emerged from industry needs and the course content has been designed to meet this industry need. This module covers the core aspects of interpreting and/or setting quality characteristics and their verification through appropriate calibrated Inspection, Measurement and Testing processes. The module traces the metrological requirements from quality characteristics through instrument selection, evaluation and on-going calibration so that the student is fully aware of the purpose and operation of a good measurement management system.

1. Interpret and explain the relevance of calibration within a GMP and Quality Assurance environment.
2. Describe the various metrological requirements from quality characteristics through instrument selection, evaluation and ongoing calibration
3. Outline the properties of a good measurement management system and how it links to validation
4. Interpret the key elements in a systematic approach to validation with an emphasis on medical device manufacture
5. Critique risk analysis and evaluation and how it relates validation
6. Source and interpret the industry standard guidelines in use for validation within a GMP environment.
7. Outline elements of validation documentation and understand the regulatory requirements and the use of risk management tools in making regulatory decisions.