Quality for Industry
Bachelor of Science
Sonraí an Chúrsa
Course Code | GA_SQUAG_B07 |
---|---|
Céim | 7 |
Fad ama | 2/3 years |
Creidmheasanna | 60 |
Modh Seachadta | Blended |
Suímh campais | Galway City – Dublin Road |
Modh Seachadta | Páirtaimseartha |
![Quality for Industry](https://www.atu.ie/app/uploads/2024/10/dublin-road-students-in-library-640x0-c-default.webp)
Forbhreathnú Cúrsa
This Bachelor of Science (Level 7) in Quality for Industry offers you a path to obtain an Ordinary (Level 7) degree, assuming you have a Higher Certificate in Business, Engineering or Science.
Sonraí an Chúrsa
Bliain 1
Seimeastar | Sonraí an Mhodúil | Creidmheasanna | Éigeantach / Roghnach |
---|---|---|---|
1 |
ValidationThis 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. Torthaí Foghlama 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. |
05 | Mandatory |
1 |
Production and Supervisory ManagementThis module gives an overview of operational systems and the roles and responsibilities of a production supervisor Torthaí Foghlama 1. Apply the principles of operationsmanagement 2. Demonstrate leadership in achieving organisational goals and objectives 5. Demonstrate the ability to disseminate information using appropriate channels |
05 | Mandatory |
2 |
Clean Room ManagementThis module aims to provide the student with the knowledge to understand and manage clean room environments. Torthaí Foghlama 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 |
05 | Mandatory |
2 |
Six Sigma for Quality ManagementThis 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. Torthaí Foghlama 1. Describe the role of Six Sigma as part of an organizations quality management system 5. Develop plans for continuous improvement |
05 | Mandatory |
Year |
ProjectAn 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. Torthaí Foghlama 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 |
10 | Mandatory |
Year |
Regulatory Affairs and Compliance AuditingThis 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. Torthaí Foghlama 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. |
10 | Mandatory |
Year |
Quality Management Part IQuality Assurance systems and general management principles in manufacturing and service organizations. Torthaí Foghlama 1. Have a good knowledge of quality management principles. |
10 | Mandatory |
Year |
Quality Management Part IIQuality Management philosophies and their application. Torthaí Foghlama 1. Have a thorough knowledge of the philosophies of quality management and their place in todays quality movement. |
10 | Mandatory |
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Riachtanais Iontrála
To obtain the Bachelor of Science (Level 7) in Quality for Industry at ATU you need to have the following:
- 60 credits at Level 7 (the three Certificates below) plus
- 120 credits at Level 6 in a suitable/specified discipline (or a successful RPL application).
Note: All levels and credits referenced are per the National Framework of Qualifications (NFQ)
1. 60 Credits at Level 7:
Currently ATU are offering 60 credits at Level 7
- Certificate in Science in Quality Management (20 credits at Level 7)
- Certificate in Science in Quality and Regulatory Affairs (20 credits at Level 7)
- Certificate in Science in Quality Statistics and Management (20 credits at Level 7)
While each of the above three certificates are awarded individually, students who have completed all three Certificates may wish to apply for the add on Bachelor of Science in Quality for Industry Degree provided they have 120 credits at Level 6 in a suitable/specified discipline as outlined below.
2. 120 credits at Level 6 in a suitable/specified discipline.
To provide evidence of compliance with this requirement, you must either:
(a) already have a Level 6 award (120 credits at Level 6) OR
(b) have been successful in obtaining an exemption from the requirement through an application to the Recognition of Prior Learning (RPL) http://www.myexperience.ie
Further Information
Cé Ba Chóir Iarratas a Dhéanamh?
Suitable to those seeking career progression in the areas of Quality Technician, Quality Engineer/Quality Managers and Quality Subject Matter Experts (SME’s) on quality related issues.
Eolas Teagmhála
E: learn.galwaymayo@atu.ie
Analytical, Biopharmaceutical & Medical Sciences