Postgraduate Diploma in Quality Management and Validation

Program Overview

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

Course Overview

This course 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.

Funding Opportunities

This programme will be funded by Springboard+ for the academic year 2025/2026. It will open for applications on Tuesday, 3rd June.

Entry Requirements

• Candidates should hold a recognized level 8 honors degree in a non-quality discipline.
• Those with a level 7 degree in any non-cognate discipline with three years post-qualification and/or those who meet the Recognition of Prior Learning (RPL) requirements as per the University RPL policy will also be considered.
• In line with University policies, non-native English speakers are required to have an IELTS level of 6.5 or higher.

Course Content

Modules

• Strategic Management and Leadership
  • Module Aim: Strategic Management concerns the positioning of an organization in order to gain a competitive advantage.
  • Learning Outcomes:
    • Apply an applied knowledge of the key issues related to the strategic management of organizations in a dynamic changing environment.
    • Critically analyze the relationship between strategic management, competitive advantage, and profitability.
    • Critically evaluate the analytical techniques associated with strategy formation at business and corporate levels.
    • Formulate strategies appropriate to an organization’s context and capabilities.
    • Synthesize and integrate business decisions with key developments of the changing environment relating to technology, globalization, and ESG (Environmental, Social Governance).
    • Appraise the role of leadership in the effective formulation and implementation of successful strategies.
• 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.
  • Learning Outcomes:
    • 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.
    • Critically appraise project management tools and techniques to prepare schedules, cost analyses, and reports through the use of computerized project management systems.
    • Critically appraise the various Qualitative and Quantitative risk analysis methods.
    • Engage in the application of concepts of Reliability Engineering to determine and extend the useful life of products.
    • Critically debate the specialized methods and techniques for modeling and managing risk.
    • Critically evaluate the importance of risk in relation to relevant ISO Standards.
• Quality Management, Standards and Good Manufacturing Practice
  • Module Aim: To give students an understanding of how quality is managed in a manufacturing or services organization and to give them an introduction to current tools and philosophies in the area of quality management.
  • Learning Outcomes:
    • Illustrate an applied knowledge of Quality, Quality Control, Quality Assurance, GxP, and cGmP.
    • Critique the various problem-solving tools and techniques used for quality improvement.
    • Critically analyze specific GMP principles to the published regulatory documents applicable to the global pharmaceutical/biopharmaceutical industry.
    • Critically appraise the role of GMP from initial drug trials to commercial product launch and subsequent pharmacovigilance market surveillance.
    • 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.
    • Differentiate the roles of the various regulatory bodies across a range of industry sectors.
• 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.
  • Learning Outcomes:
    • 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.
    • Critically apply a knowledge of acceptance sampling and ANSI sampling plans.
    • Critically interpret and report a data set, in terms of choosing, analyzing, and presenting a suitable Control Chart.
    • Critique the role of validation within Good Manufacturing Practice by applying the various validation guidelines, standards, and risk management tools.
    • Demonstrate an applied knowledge of calibration and preventative maintenance in a GMP environment.
    • Critically analyze calibration protocols and techniques to determine uncertainties of measure and errors in measuring/analytical instruments.
• Research Methods
  • Module Aim: This module aims to introduce participants to the key concepts involved in research.
  • Learning Outcomes:
    • Critically appraise a knowledge and critical understanding of research methodologies and techniques, as appropriate to the preparation of a dissertation at Level 9.
    • Critically compare alternative research techniques and evaluate their uses and limitations.
    • Synthesize a detailed project plan, incorporating the requirements of scope, schedule (time), budget (cost), quality, and risk.
    • Critically analyze the performance of a project in relation to how the outcomes fulfilled the outlined objectives and requirements.
    • 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.
    • Develop a research proposal that will meet the criteria established for the project element of this program.
• Applied Case Studies Capstone Project
  • Module Aim: This module affords students the opportunity to implement the core skills learned in the taught modules.
  • Learning Outcomes:
    • Critically engage with the research literature and synthesize a suitable and relevant proposal.
    • Consolidate and extend specialized knowledge relevant to the program of study and understand the challenges and specific requirements of working on industry-focused projects.
    • 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.
    • Contextually relate theory to practice through solving work-based problems and contributing meaningfully to the employer/work-based learning organization.
    • Demonstrate independence, self-reliance, moral, and ethical judgment in the context of professional decision-making and leadership and communicate effectively using both verbal and written skills.
    • Critically apply the core attributes of a practitioner through the delivery of a project in their discipline.

Career Opportunities

Quality Management profession can be very rewarding and nowadays it is appreciated as a core aspect of the Senior Management Team in all businesses. Graduates of this program have secured enhanced promotional opportunities in their own organizations or new roles in Advanced Manufacturing, Pharmaceutical, and Medical Device Sectors.

Objectives

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.

Timetable Info

• Induction: Saturday, 6th September 2025, from 9:00 am to 1:00 pm.
• Programme Delivery: 1 Year, Two evenings per week ONLINE, PLUS 4 Saturdays per semester ONLINE.

Fees

This program will be fully funded for eligible unemployed applicants. Eligible employed applicants and eligible recent graduates (Summer 2024) will be 90% funded. They will have to pay 10% directly to TUS Midlands. The 10% payable is €850.

Program Outline

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Degree Overview:

The Postgraduate Diploma in Quality Management and Validation is a Level 9 program (60 ECTS) designed to provide participants with a comprehensive understanding of Quality Management and Validation theory and practice. It is delivered full-time through a blended learning approach, combining facilitated workshops and online virtual learning classes. The program emphasizes participatory learning and teaching methods, with a strong focus on collaborative group work.

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Objectives:

The program aims to:

• Develop appropriate intellectual and personal skills.
• Offer participants the opportunity to gain a detailed knowledge of the underpinning theory and effective practice of Quality Management and Validation.
• Equip participants with the necessary competencies to:
• 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.

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Outline:

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Structure:

• The program is delivered over two semesters.

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Modules:

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Semester 1:

• Strategic Management and Leadership: This module explores the principles of strategic management and leadership in the context of quality management.
• Quality Management, Standards and Good Manufacturing Practice: This module examines the fundamentals of quality management, including relevant standards and good manufacturing practices.

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Semester 2:

• Statistical Process Control, Calibration and Validation: This module focuses on statistical process control techniques, calibration procedures, and validation methods used in quality management.
• Research Methods: This module introduces participants to research methodologies and data analysis techniques relevant to quality management.
• Applied Case Studies Capstone Project: This module provides participants with the opportunity to apply their knowledge and skills to real-world case studies and complete a capstone project.

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Course Schedule:

• Induction: The induction for the September 2024 program takes place online via Zoom on Saturday, 7th September 2024, from 10:00 am to 1:00 pm.
• Delivery: The program is delivered primarily online, with occasional in-person examinations at TUS, Athlone Campus.
• Frequency: Three evenings per week online, plus occasional Saturdays online.
• Lectures: Lectures are delivered live online, and recordings are available for students to view at their convenience.

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Teaching:

• Methods: The program utilizes a blended learning approach, combining facilitated workshops and online virtual learning classes.
• Faculty: The program is taught by experienced faculty with expertise in quality management and validation.
• Unique Approaches: The program emphasizes participatory learning and teaching methods, with a strong focus on collaborative group work.

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Careers:

• Potential Career Paths: Graduates of this program are well-prepared for a range of careers in quality management and validation, including:
• Quality Manager
• Quality Assurance Specialist
• Validation Engineer
• Regulatory Affairs Specialist
• Process Improvement Specialist
• Opportunities: The quality management profession is in high demand, offering rewarding career opportunities in various industries, including advanced manufacturing, pharmaceuticals, and medical devices.
• Outcomes: Graduates of this program have secured enhanced promotional opportunities within their organizations or new roles in the aforementioned sectors.

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Other:

• Partnership: The program is developed in partnership with the Midlands Regional Skills Manager and relevant industry partners.
• Support: The program provides a personal and supportive approach to teaching and learning.
• Government Focus: The program addresses four key areas deemed critical by the government: digital skills, transversal skills, management and leadership skills, and the workplace of the future.

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This is a HCI Funded Programme. This programme will be fully funded for eligible unemployed applicants. Eligible employed applicants and eligible recent graduates will be 90% funded. They will have to pay 10% directly to TUS Midlands. The 10% payable is €850.