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MGMT7047 - Technology Transfer

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Title:Technology Transfer
Long Title:Technology Transfer
Module Code:MGMT7047
 
Duration:1 Semester
Credits: 5
NFQ Level:Intermediate
Field of Study: Business & Management
Valid From: Semester 1 - 2016/17 ( September 2016 )
Module Delivered in 2 programme(s)
Module Coordinator: NIALL MORRIS
Module Author: ANN TOEBES
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:
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.
Pre-requisite learning
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 CIT 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
 

Module Content & Assessment

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.
Assessment Breakdown%
Course Work50.00%
End of Module Formal Examination50.00%
Course Work
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Short Answer Questions written examination 1,2 20.0 Week 6
Presentation Project and presentation 2,3,4 30.0 Week 10
End of Module Formal Examination
Assessment Type Assessment Description Outcome addressed % of total Assessment Date
Formal Exam End-of-Semester Final Examination 1,2,3,4 50.0 End-of-Semester
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 institute reserves the right to alter the nature and timings of assessment

 

Module Workload

Workload: Full Time
Workload Type Workload Description Hours Frequency Average Weekly Learner Workload
Lecture Classroom Instruction 2.75 Every Week 2.75
Lecturer-Supervised Learning (Contact) Project Guidance 0.5 Every Second Week 0.25
Independent & Directed Learning (Non-contact) Study 4.0 Every Week 4.00
Total Hours 7.25
Total Weekly Learner Workload 7.00
Total Weekly Contact Hours 3.00
Workload: Part Time
Workload Type Workload Description Hours Frequency Average Weekly Learner Workload
Lecture Class room instruction 2.75 Every Week 2.75
Lecturer-Supervised Learning (Contact) Project Guidance 0.5 Every Second Week 0.25
Independent & Directed Learning (Non-contact) Student Input 4.0 Every Week 4.00
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 Ed., 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
 

Module Delivered in

Programme Code Programme Semester Delivery
CR_ECPEN_8 Bachelor of Engineering (Honours) in Chemical and Biopharmaceutical Engineering 4 Elective
CR_SGMPR_7 Bachelor of Science in Good Manufacturing Practice and Technology 1 Mandatory

Cork Institute of Technology
Rossa Avenue, Bishopstown, Cork

Tel: 021-4326100     Fax: 021-4545343
Email: help@cit.edu.ie