Postgraduate Diploma in Quality Management and Validation (L9, 60 ECTS)

Semester 1 

Strategic Management and Leadership 

Project Management, Reliability Engineering and Risk Management 

Quality Management, Standards and Good Manufacturing Practice 

Semester 2 

Statistical Process Control, Calibration and Validation 

Research Methods 

Applied Case Studies Capstone Project 

Module 1: Strategic Management and Leadership 

Module Aim 

Strategic Management concerns the positioning of an organisation in order to gain a competitive advantage. The module will focus on strategy as a link between the organisation and its internal capabilities, as well as meeting the complexities of the external environment. The module will demonstrate to the learner how to make and implement key strategic decisions. The successful implementation of effective strategies requires leadership. The module will explore the critical role of leadership in strategy formulation and implementation, organisational development and organisational growth. It will analyse how leaders behave and develop, how different leaders deploy different leadership styles and their effectiveness in differing contexts. 

Learning Outcomes 

1. Apply an applied knowledge of the key issues related to the strategic management of organisations in a dynamic changing environment. 
2. Critically analyse the relationship between strategic management, competitive advantage, and profitability. 
3. Critically evaluate the analytical techniques associated with strategy formation at business and corporate levels. 
4. Formulate strategies appropriate to an organisation’s context and capabilities. 
5. Synthesise and integrate business decisions with key developments of the changing environment relating to technology, globalisation, and ESG (Environmental, Social Governance). 
6. Appraise the role of leadership in the effective formulation and implementation of successful strategies.

Module 2: Project Management, Reliability Engineering and Risk Management 

Module Aim 

This module introduces candidates to the fundamentals of project management and the steps involved in managing a project from concept to completion. The module enforces the importance of adequate planning in order to prepare a thorough baseline to manage and control the project with an emphasis on ethics and social responsibility throughout this process. The module will introduce the student to the concepts and roles of Risk Management in modern organisations. The module will explore the critical importance of Reliability Engineering in meeting customers’ and organisations’ expectations. 

Learning Outcomes 

1. Apply a detailed knowledge of planning and executing the different stages of a project, incorporating the requirements of time, cost, quality, risk in a sustainable manner. 
2. Critically appraise project management tools and techniques to prepare schedules, cost analyses and reports through the use of computerised project management systems 
3. Critically appraise the various Qualitative and Quantitative risk analysis methods. 
4. Engage in the application of concepts of Reliability Engineering to determine and extend the useful life of products. 
5. Critically debate the specialised methods and techniques for modelling and managing risk. 
6. Critically evaluate the importance of risk in relation to relevant ISO Standards.

Module 3: Quality Management, Standards and Good Manufacturing Practice 

Module Aim 

To give students an understanding of how quality is managed in a manufacturing or services organisation and to give them an introduction to current tools and philosophies in the area of quality management. The module will explore the application standards such as ISO, EudraLex legislation, the CE directives, the Machineries directive, the EMC directives as they apply to individual manufacturing operations. This module will identify the role of the regulatory bodies FDA (US Food and Drug Administration), the EMA (the European Medicines Agency), the European Food Safety Authority, and give the student the ability to identify the regulators which have required jurisdiction. This module will provide the students with an understanding of the use of standards and guidance documents such as the cGMPs (current Good Manufacturing Practices) provided by the FDA, EMA, WHO. PIC/S (The Pharmaceutical Inspection Co-operation Scheme), the European Food Safety Authority and other bodies. 

Learning Outcomes 

1. Illustrate an applied knowledge of Quality, Quality Control, Quality Assurance, GxP and cGmP. 
2. Critique the various problem-solving tools and techniques used for quality improvement.
3. Critically analyse specific GMP principles to the published regulatory documents applicable to the global pharmaceutical / biopharmaceutical industry 
4. Critically appraise the role of GMP from initial drug trials to commercial product launch and subsequent pharmacovigilance market surveillance; 
5. Critically evaluate the requirements of the international standards ISO 9001:2015, ISO 13485:2016, ISO 14001:2015 and ISO 45001:2018 (all,as amended) as they apply to various manufacturing environments 
6. Differentiate the roles of the various regulatory bodies across a range of industry sectors.

Module 4: Statistical Process Control, Calibration and Validation 

Module Aim 

This module addresses the theories and concepts of Statistical Process Control (SPC) used in monitoring and controlling the quality of a process through statistical analysis to reduce variation. The module aims to ensure that students gain the ability to construct and interpret control charts for variables and attributes, to undertake capability analysis and demonstrate an understanding of the important relationship between capability analysis and process stability as observed on control charts. 

Learning Outcomes 

1. Critically evaluate the role and contribution of Statistical Process Control to a total quality environment, demonstrating an applied knowledge of the role of Statistical Process Control in determining process capability. 
2. Critically apply a knowledge of acceptance sampling and ANSI sampling plans. 
3. Critcally interpret and report a data set, in terms of choosing, analysing and presenting a suitable Control Chart. 
4. Critique the role of validation within Good Manufacturing Practice by applying the various validation guidelines, standards and risk management tools 
5. Demonstrate an applied knowledge of calibration and preventative maintenance in a GMP environment 
6. Critically analyse calibration protocols and techniques to determine uncertainties of measure and errors in measuring/analytical instruments

Module 5: Research Methods 

Module Aim 

This module aims to introduce participants to the key concepts involved in research. The material covered in this module will form the basis for the research dissertation element of the programme while also developing a framework of research and analysis for participants to approach research in their work environment by equipping learners to critically explore the development and completion of applied research methodologies using structured, responsible tools and actions while imbuing learners with work-ready skills for industrial practice. 

Learning Outcomes 

1. Critically appraise a knowledge and critical understanding of research methodologies and techniques, as appropriate to the preparation of a dissertation at Level 9. 
2. Critically compare alternative research techniques and evaluate their uses and limitations. 
3. Synthesise a detailed project plan, incorporating the requirements of scope, schedule (time), budget (cost), quality and risk. 
4. Critically analyse the performance of a project in relation to how the outcomes fulfiled the outlined objectives and requirements. 
5. Apply the key concepts and perform the tasks involved in completing a research project and articulate how these interrelate in a complementary way to form a coherent research proposal. 
6. Develop a research proposal that will meet the criteria established for the project element of this programme.

Module 6: Applied Case Studies Capstone Project 

Module Aim 

This module affords students the opportunity to implement the core skills learnt in the taught modules. Students will be required to make a proposal and it will form the basis of an applied project that will demonstrate the ability to engage as a skilled practitioner in their discipline. The aim of the module is to encourage learners to develop integrative learning, independent thought and critical reflection skills as they bring together a range of concepts, theories, frameworks and practices. They will also be expected to practice competences developed within other modules. 

Learning Outcomes 

1. Critically engage with the research literature and synthesise a suitable and relevant proposal 
2. Consolidate and extend specialised knowledge relevant to the programme of study and understand the challenges and specific requirements of working on industry focused projects. 
3. Develop and display the competence to conduct research and manage projects in a methodologically sound and ethical manner while giving due consideration to the social and legal context of the tasks. 
4. Contextually relate theory to practice through solving work-based problems and contributing meaningfully to the employer / work based learning organisation. 
5. Demonstrate independence, self-reliance, moral and ethical judgement in the context of professional decision making and leadership and communicate effectively using both verbal and written skills. 
6. Critically apply the core attributes of a practitioner through the delivery a project in their discipline.

This programme will be delivered online.

This programme is designed to offer participants the opportunity to gain a detailed knowledge of the underpinning theory and effective practice of Quality Management and Validation which will be of particular benefit in a range of management and leadership roles as well as in specialized Quality Management and Validation roles.

Quality Management profession can be very rewarding and nowadays it is appreciated as a core aspect of the Senior Management Team in all businesses.

Quality Management covers everything, from audits, to complaints, to regulations and many more areas.

Graduates of this programme have secured enhanced promotional opportunities in their own organisations or new roles in Advanced Manufacturing, Pharmaceutical and Medical Device Sectors.

The aim of the Postgraduate Diploma in Quality Management and Validation is to provide an educational experience that enables participants to achieve an integrated understanding of the operation and strategy of Quality Management and Validation, and to develop appropriate intellectual and personal skills.

Specifically the programme is designed to offer participants the opportunity to gain a detailed knowledge of the underpinning theory and effective practice of Quality Management and Validation which will be of particular benefit in a range of management and leadership roles as well as in specialized Quality Management and Validation roles.

After successfully completing the programme, participants will have demonstrated the competencies necessary to:
• Adopt analytical, systematic approaches toward problem solving and decision making, while simultaneously displaying an appropriate awareness and understanding of the sensitivities involved in the context of organisational dynamics;
• Demonstrate personal qualities of empathy, leadership, teamworking;
• Manage their own learning and development, and evaluate their own experience through a reflective approach towards the impact of the programme on their lives;
• Be catalysts of change within their employing organisations, as a result of the adoption of creative and innovative approaches to opportunities and threats.

Three evenings per week Online
PLUS occasional occasional Saturdays Online

Lectures will be delivered live online, and recordings of lectures will be available to view in the student’s own time.

€5,000