The aim of this module is to:
Part I – Validation for Medical Devices
Introduce the student to the regulatory frame work in which pharmaceuticals are controlled, with particular emphasis on medical devices. A further aim is to give the student a comprehensive understanding on Good Manufacturing practices, and Validation and how it applies to the manufacture of Medical Devices.
Part II – Statistical Process Control and Experimental Design
Introduce the student to Statistical Process Control techniques
Introduce the student to industrial problem solving techniques, particularly experimental design.
Part III - Health and Safety in the Industrial and Laboratory Environment
Introduce the student to the legislative framework associated with Health and Safety. To give the student an appreciation of the issues related to Health and Safety and to inculcate in them the need for adherence to regulations at all times. This part of the module will provide students with a working knowledge of Health and Safety thus preparing them to undertake formal Health and Safety training in the industry/laboratory in which they will later work. To introduce students to the application of scientific knowledge relating to radiation safety and its translation into legislation.
Part I – Validation for Medical Devices
History of the regulation of Medicines and medical devices in Ireland, Europe and USA
The regulation of Medical Devices
Good Manufacturing Practice with respect to Medical Devices
Validation of Medical Devices
Part II – Statistical Process Control and Experimental Design
Introduction, background and basic concepts of Statistical Process Control. Sensing and measurement in industrial processes. Statistical methods in Quality Improvements. Methods and implementation of Statistical Process Control. Measurement and control of process using variable data. Process capability and variables.
Process problem solving and improvement. Problem solving and trouble shooting in out of control processes. Pareto analysis. Cause and effect analysis. Process design and improvement using designed experiments. Fundamental principles of designed experiments. Factorial and fractional experiments for process design. Optimisation techniques and methods. Taguchi method of experimental design.
Part III - Health and Safety in the Industrial and Laboratory Environment
Health and Safety Legislation, Statutory law and Common Law.
The Employers Act
Risk analysis and safety audits
Lectures incorporating presentation of theory, discussions and problem solving.
| Module Content & Assessment | |
|---|---|
| Assessment Breakdown | % |
| Formal Examination | 70 |
| Other Assessment(s) | 30 |