This module covers the science and practice of validation, as it applies within the pharmaceutical and medical device sectors, with particular focus on computerised/automated systems. The use of risk management as part of the validation process is also covered.

1. Explain the regulatory basis for validation and the role of validation within Good Manufacturing Practice.

2. Describe the major steps involved in the validation of critical pharmaceutical and medical device manufacturing operations, including equipment, process, cleaningand test method validation.

3. Appreciate the growing dependence on automated systems, software anddata in a manufacturing context and the importance of equipment and automated system validation and data integrity.

4. Prepare a validation / qualification documentand complete risk assessmentexercises in accordance with regulatory guidelines and industry best practice.

5. Recognise opportunities for more sustainable practice within industry,specifically with respect to electronic record and data management.

This module gives an overview of operational systems and the roles and responsibilities of a production supervisor

1. Apply the principles of operationsmanagement

2. Demonstrate leadership in achieving organisational goals and objectives
3. Prioritise production activities based on business needs
4. Identify and applyrelevantapproaches for process analysis and improvement

5. Demonstrate the ability to disseminate information using appropriate channels

This module aims to provide the student with the knowledge to understand and manage clean room environments.

1. Explain the principles of cleanroom design and construction

2. Apply standards and regulations in cleanroom operation.

3. Describe the requirements for monitoring and testing the cleanroom environment.

4. Identifysources of contamination and implement control systems

This module covers the relevant Six Sigma tools and their application to Practitioners of Quality Management (Quality Technicians, Quality Engineers, and Quality Managers etc). It will connect the use of Six Sigma tools and techniques with traditional Quality Management tools, for example, the use of DMAIC or the Structured Problem Process in the CAPA process. It will give the student statistical tools that are required for data analysis and problem solving. It also describes how Six Sigma and Quality Management both strive for Continuous Improvement.

1. Describe the role of Six Sigma as part of an organizations quality management system
2. Perform various analyses such as DMAIC and Structured Problem Solving.
3. Identify and apply relevant quality tools to manufacturing issues, such tools to include cycle time reduction, risk analysis, kaizen and waste elimination.
4. Apply probability and statistical rules and concepts.

5. Develop plans for continuous improvement

An independent project is completed by the learner. The project is normally based in industry Students are supervised during their project, but are expected to complete most of their work independently.

1. Develop a project plan, clearly stating the purpose of the project and the approach/methodology used.

2. Source scientific and/or regulatory literature to support your project approach

3. Design and undertake appropriate work,analyse findings and document results

4. Reflect on the project results, articulate conclusions and make recommendations for improvement/future work in this area

5. Present, defend and justifythe outcomes of the product

This module reviews the latest European and US regulations for pharmaceutical and medical devices. The quality system standards/regulations/guidelines are reviewed for Europe and the US and the auditing approaches used to demonstrate compliance are explored.

1. Evaluate the EU and FDA Quality System requirements for medical devices and pharmaceuticals

2. Interpret themarketing authorizationand regulatory pathwaysfor pharmaceuticals and medical devicesin the EU and the US.

3. Explain the principles,requirements and practices of compliance auditing

4. Detail a system for investigation of non-conformances, identification of root cause and corrective / preventive actions.
5. Participate in an audit, identifying any non-conformances and generation of an audit report

Quality Assurance systems and general management principles in manufacturing and service organizations.

1. Have a good knowledge of quality management principles.
2. Explain how quality is managed in a manufacturing and service organization.
3. Explain the methodology of quality improvement and apply various tools and techniques for analysis of quality.
4. Apply a range of problem solving tools.
5. Use statistical basic process control tools
6. Understand the ISO 9000 quality management standards
7. Complete audits against elements of the ISO standard

Quality Management philosophies and their application.

1. Have a thorough knowledge of the philosophies of quality management and their place in todays quality movement.
2. Critically analyze and improve their own communication skills and to understand the importance of communication in the world of quality.
3. Understand the role of leadership, human resource management, customer focus and team work in promoting and achieving quality standards in an organization.
4. Critically analyze an organization and design and implement various systems and procedures with regard to quality management in that organization.
5. Critically review new developments in quality and apply them as necessary.
6. Interpret and describe industry specific standards appropriate to the students field of work including for example ISO 13485
7. Analyse and apply a range of process management, continuous improvement, Lean and Six Sigma tools and concepts, financial and performance measures in quality management.