Module Details
| Module Code: |
MGMT7047 |
| Title: |
Technology Transfer
|
|
Long Title:
|
Technology Transfer
|
| NFQ Level: |
Intermediate |
| Valid From: |
Semester 1 - 2016/17 ( September 2016 ) |
| Field of Study: |
3450 - Business & Management
|
| Module Description: |
The process of transferring products and processes from research to manufacturing or from one location to another and involves, life cycle studies, raw material impacts, pilot plant studies, validation, commissioning and cleaning.
|
| Learning Outcomes |
| On successful completion of this module the learner will be able to: |
| # |
Learning Outcome Description |
| LO1 |
Assess critical issues in the transition from research project to product launch in the Pharmaceutical and Medical Device industry. |
| LO2 |
Critically analyse the key aspects of the technology transfer process. |
| LO3 |
Assess the environmental and safety factors that influence technology transfer decisions. |
| LO4 |
Present a project detailling critical aspects in technology transfer. |
| Dependencies |
Module Recommendations
This is prior learning (or a practical skill) that is strongly recommended before enrolment in this module. You may enrol in this module if you have not acquired the recommended learning but you will have considerable difficulty in passing (i.e. achieving the learning outcomes of) the module. While the prior learning is expressed as named MTU module(s) it also allows for learning (in another module or modules) which is equivalent to the learning specified in the named module(s).
|
| Lean Manufacturing,
Validation Science
|
Incompatible Modules
These are modules which have learning outcomes that are too similar to the learning outcomes of this module. You may not earn additional credit for the same learning and therefore you may not enrol in this module if you have successfully completed any modules in the incompatible list.
|
| No incompatible modules listed |
Co-requisite Modules
|
| No Co-requisite modules listed |
Requirements
This is prior learning (or a practical skill) that is mandatory before enrolment in this module is allowed. You may not enrol on this module if you have not acquired the learning specified in this section.
|
| No requirements listed |
| Indicative Content |
|
Concept to sale of product
Pharmaceutical and Biopharmaceutical: Regulatory Life cycle: FDA and EU approval processes. Product life cycle: Bench top reactions, kilo lab, pilot plant, large scale pilot plant, full scale manufacturing. And/or
Devices: Regulatory Life cycle: FDA and EU approval processes. Product Life Cycle: R+D Lab, Pilot, Prototype, Manufacturing the product.
|
|
Validation issues in Technology Transfer
Review of lifecycle approach to validation and associated regulatory guidelines. ICH Q8 Quality by Design. ICH Q9 Quality Risk Management. Validation conducted during technology transfer. Good Engineering Practice. Vendor appraisal and raw material qualification. Training.
|
|
Pilot-plant studies
Scale-up studies: Yield comparisons, physical properties and impurities, heat transfer issues. Route selection. Development of effective cleaning methods.
|
|
Full Scale Manufacturing
Process fit with existing facilities. Inclusion of Process Analytical Technology. Utility requirements. REACH compliance. Environmental and health and safety considerations. Process automation, maintenance. Materials management.
|
|
Module Content & Assessment
|
| Assessment Breakdown | % |
|---|
| Coursework | 50.00% |
| End of Module Formal Examination | 50.00% |
Assessments
| End of Module Formal Examination |
|
|
| Reassessment Requirement |
Repeat examination
Reassessment of this module will consist of a repeat examination. It is possible that there will also be a requirement to be reassessed in a coursework element.
|
The University reserves the right to alter the nature and timings of assessment
Module Workload
| Workload: Full Time |
| Workload Type |
Contact Type |
Workload Description |
Frequency |
Average Weekly Learner Workload |
Hours |
| Lecture |
Contact |
Classroom Instruction |
Every Week |
2.75 |
2.75 |
| Lecturer-Supervised Learning (Contact) |
Contact |
Project Guidance |
Every Second Week |
0.25 |
0.5 |
| Independent & Directed Learning (Non-contact) |
Non Contact |
Study |
Every Week |
4.00 |
4 |
| Total Hours |
7.25 |
| Total Weekly Learner Workload |
7.00 |
| Total Weekly Contact Hours |
3.00 |
| Workload: Part Time |
| Workload Type |
Contact Type |
Workload Description |
Frequency |
Average Weekly Learner Workload |
Hours |
| Lecture |
Contact |
Class room instruction |
Every Week |
2.75 |
2.75 |
| Lecturer-Supervised Learning (Contact) |
Contact |
Project Guidance |
Every Second Week |
0.25 |
0.5 |
| Independent & Directed Learning (Non-contact) |
Non Contact |
Student Input |
Every Week |
4.00 |
4 |
| Total Hours |
7.25 |
| Total Weekly Learner Workload |
7.00 |
| Total Weekly Contact Hours |
3.00 |
|
Module Resources
|
| Recommended Book Resources |
|---|
-
International Society for Pharmaceutical Engineering. (2003), ISPE Good Practice Guide: Technology Transfer, International Society for Pharmaceutical Engineering, [ISBN: 1-931879-13-3].
| | Supplementary Book Resources |
|---|
-
Robert A., Wachter, Alfred, H. (2003), 1. Pharmaceutical Process Validation (Drugs and the Pharmaceutical Sciences: a Series of Textbooks and Monographs), Third Edition. Informa Healthcare, [ISBN: 10:0824709385, ISBN-13: 9780824708382].
-
Joachim; Miller, John, H., McB. (2005), 2. Method Validation in Pharmaceutical Analysis: A Guide to Best Practice,, John Wiley & Sons,, [ISBN: 10: 3527312552 ; ISBN-13: 978-3527312559].
| | This module does not have any article/paper resources |
|---|
| Other Resources |
|---|
-
Website, Food and Drug Administration,
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Website, International Society for Pharmaceutical
Engineering,
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Website, European Medicines Agency,
-
Website, International Conference on
Harmonisation,
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|
