PH3S108 - Regulations for the Manufacture of Combination & Device Products 01 Jan 2022 - 31 Aug 2028 | Version 1
Associated Module Information
| Module Code: | PH3S108 | ||
|---|---|---|---|
| Module Title: | Regulations for the Manufacture of Combination & Device Products | ||
| Faculty: | Faculty of Computing, Engineering and Science | ||
| Faculty Group: | Applied Sciences | ||
| Faculty Sub Group: | Chemistry and Pharmaceutical Science | ||
| Module Leader: | |||
| Module Team: | Suzanna Kean | ||
| First Intended Intake: | Final Year of Intake: | ||
| Date Closed: | |||
| Credit Value: | 20 | Credit Level: | 6 |
| Language: | English | ||
| Percentage of Module Taught in Welsh: | 0 | ||
| Equivalent Module: | |||
| HECOS codes: | 100078 - business and management | 100144 - pharmaceutical engineering | 100185 - safety engineering |
| HECOS Code Weighting: | 35 | 35 | 30 |
Document Version Information
| Version | 1 |
|---|---|
| Valid From | 01 Jan 2022 |
| Valid To | 31 Aug 2028 |
Module Aims
The aim of the module is to give students a broad understanding of the regulations underpinning the manufacture of safe combination and device products for the public, including the regulatory environment for combination products and medical devices, and the Quality Management System (QMS) necessary for the reliable delivery of high-quality products across a selection of manufacturing technologies.
Content Summary
The module will explore:
• The regulatory environment for combination products and medical devices
• The key elements of a robust Quality Management System (QMS) necessary for the reliable delivery of high quality products
• The Fundamentals of validation for combination products
• An introduction to selected manufacturing technologies involved in the manufacture of combination and device products
Indicative Syllabus:
• Overview of Combination Products & Medical Device Regulations (US,EU, ISO13485, etc).
• Navigating the Design, Design Control, Design Verification Process
• Quality Management Systems including Effective Change Management, Proactive CAPA management
• Verification versus Validation in Med Tech sector – including; Applying Risk Management to the Validation Process
• Supply Chain Management – The importance of building successful supplier partnerships and the role of supplier qualification, auditing and purchasing controls.
This module is delivered through open/distance learning resource packs, pre-recorded lectures, problem-solving exercises and case studies.
Learning and Teaching Methods
| Activity Type | Hours |
|---|---|
| Independent Study | 100 |
| Directed Study | 86 |
| Formative Assessment - Independent | 14 |
| Total Hours Selected | 200 |
Learning Outcomes
| # | Learning Outcome |
|---|---|
| LO1 | Demonstrate an understanding of current regulatory environment for the manufacture of combination products and medical devices |
| LO2 | Understand the key principles involved in the validation of and the QMS specific to the manufacture of combination products and medical devices. |
| LO3 | Demonstrate an understanding of some of the key technologies used in the manufacture of these products and the challenges associated with them. |
Module Requisites
N/A
Assessment Criteria
| Assessment Category | Assessment Type | Description | Duration | Word Count | Weight (%) | Best of? | Pass Mark |
|---|---|---|---|---|---|---|---|
| Asynchronous Assessment | Self Reflective Assessment 1 | Self reflection by the student on their academic journey to date | 0 | 400 | 10 | No | 40 |
| Asynchronous Assessment | Report 2 | Assignment case study to address the validation of a combination product or medical device product. | 0 | 3000 | 30 | No | 40 |
| Asynchronous Assessment | Report 1 | Assignment to demonstrate understanding of the regulations relating to a combination product or medical device product. | 0 | 1800 | 30 | No | 40 |
| Synchronous Online Assessment (Exam) | Online Open Book Examination (Not Proctored) 1 | Open book exam consisting of a series of short questions on the module content | 180 | N/A | 30 | No | 40 |
Assessment Matrix
| Assessment Type | Learning Outcomes | ||
|---|---|---|---|
| LO1 | LO2 | LO3 | |
| Self Reflective Assessment 1 | ✔ | ✔ | ✔ |
| Report 2 | ✔ | ✔ | ✔ |
| Report 1 | ✔ | ✔ | ✔ |
| Online Open Book Examination (Not Proctored) 1 | ✔ | ✔ | ✔ |