Quality Systems and Process Excellence (Postgraduate Certificate, L9, 20 ECTS)

Quality Management, Standards and Good Manufacturing Practice

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. Emphasis on real world learning examples will be employed throughout the module, linking theoretical concepts to practical applications.

Statistical Process Control, Calibration and Validation 

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.

The module will explore the science and practice of validation and verification in regulatory-compliant environments. The module introduces
the calibration regulations and procedures and preventative maintenance requirements in a GMP environment.

Emphasis on real world learning examples will be employed throughout the module, linking theoretical concepts to practical applications.

Minimum Entry Requirements

This programme will be delivered online though our virtual learning environment.

Each 10-credit module normally equates to approximately 200 total learning hours. Total learning hours include the time spent in class, such as lectures, tutorials, and practical elements, as well as time spent working independently outside of college.

The balance between these varies by discipline and level of study, and learners should be aware that workload will increase at particular times, especially when assignments are due.

The programme is assessed through a combination of continuous assessments & project work.