Module Details

Module Code: CHEP9004
Title: Lifescience Project Management
Long Title: Lifescience Project Management
NFQ Level: Expert
Valid From: Semester 1 - 2024/25 ( September 2024 )
Duration: 1 Semester
Credits: 5
Field of Study: 5240 - Chemical & Process Eng
Module Delivered in: 1 programme(s)
Module Description: This module will provide the student with a detailed knowledge of project management (PM) specifically in the life science sector where quality and safety are paramount. GxP and sustainability concepts will be integrated with relevant project management activities, to ensure quality & safety risks are managed effectively and proactively during the term of a life science project.
 
Learning Outcomes
On successful completion of this module the learner will be able to:
# Learning Outcome Description
LO1 Ascertain key elements of new product introduction & technology transfer project management in the regulated life science sector.
LO2 Assemble and present a communication plan appropriate to the lifescience project environment.
LO3 Critically examine NPI technology transfer phases in the context of a team lifescience transfer project in terms of current quality, sustainability, and business process improvement methods.
LO4 Formulate the key components of projects and project management, including project selection and the project life-cycle.
LO5 Interpret pharmaceutical relevant PM case studies and assess the project management aspects of same.
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).
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
Introduction to Project Management
Key PM Concepts, Definition of projects, project attributes and constraints, project stakeholders, project manager, critical success factors. Alignment with business strategy, alignment with sustainability strategies and selection methods. project Initiation, stage gate project approval process, Stage 1 – project feasibility, Stage 2 – project conceptual development.
People Management
Roles & Responsibilities: The project manager, senior stakeholders, The project team, consultants & contractors, knowledge management, language & culture and communication
Risk Management
Pharmaceutical risk types, pharmaceutical quality risk management, integrated project risk management
Project Delivery Planning
Sponsor, scope, schedule, cost, controls, team, communication plan, design management strategy, technology strategy, procurement plan, construction plan, testing & commissioning strategy, project start-up strategy, project close-out & handover strategy, completion of project delivery planning.
Project Design Planning & Delivery
Stage 1 feasibility – design activities, stage 2 conceptual development – design activities, budget & schedule objectives, stage 3 project delivery planning – design activities, project stage 4 – detailed design activities, completion of design.
Project Implementation:
Procurement implementation: strategy, planning, delivery and completion. Construction implementation: construction input, preconstruction, construction delivery, construction completion. Testing & commissioning implementation: pre-requisites for testing success, delivery of the testing phase.
Project Close-Out
Handover activities, financial & contractual close-out, knowledge management, close-out check list
Case Studies:
Tech transfer project case study, electronic batch record (EBR project) project – design case study. GAMP inspection readiness project case study.
Module Content & Assessment
Assessment Breakdown%
Coursework100.00%

Assessments

Coursework
Assessment Type Project % of Total Mark 20
Timing Week 4 Learning Outcomes 4
Assessment Description
Project plan assignment
Assessment Type Written Report % of Total Mark 30
Timing Week 8 Learning Outcomes 1,2,3
Assessment Description
PM management: risk, people, delivery, design planning, sustainability, regulated life science sector and project environment. NPI transfer phases in terms of quality and business improvement methods.
Assessment Type Project % of Total Mark 50
Timing Week 13 Learning Outcomes 1,2,3,4,5
Assessment Description
Work in a team environment, prepare a detailed report and project plan document, to implement a new product introduction technology transfer project, including key components of the project management, selection and life cycle.
No End of Module Formal Examination
Reassessment Requirement
Coursework Only
This module is reassessed solely on the basis of re-submitted coursework. There is no repeat written examination.

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 Delivery of content and material underpinning learning outcomes Every Week 3.00 3
Tutorial Contact Tutorial and group work Every Second Week 0.50 1
Independent & Directed Learning (Non-contact) Non Contact Reading, study and related assignments Every Week 3.00 3
Total Hours 7.00
Total Weekly Learner Workload 6.50
Total Weekly Contact Hours 3.50
Workload: Part Time
Workload Type Contact Type Workload Description Frequency Average Weekly Learner Workload Hours
Lecture Contact Delivery of content and material underpinning learning outcomes Every Week 3.00 3
Tutorial Contact Tutorial and group work Every Second Week 0.50 1
Independent & Directed Learning (Non-contact) Non Contact Reading study and related assignments Every Week 3.00 3
Total Hours 7.00
Total Weekly Learner Workload 6.50
Total Weekly Contact Hours 3.50
 
Module Resources
Recommended Book Resources
  • Project Management Institute (COR). (2021), The Project Management and A Guide to the Project Management Body of Knowledge (PMBOK Guide), 7th. [ISBN: 9781628256642].
  • Laura Brown and Tony Grundy. (2016), Project Management for the Pharmaceutical Industry, [ISBN: 9781138247420].
  • Kathy Schwalbe. (2017), An Introduction to Project Management, 6th. Schwalbe, [ISBN: 9781544701899].
Supplementary Book Resources
  • Scott D. Babler and Sean Ekins. (2010), Pharmaceutical and Biomedical Project Management in a Changing Global Environment, [ISBN: 9780470293416].
  • Pete Harpum. (2010), Program and Project Management in the Pharmaceutical and Biotechnology Industries Portfolio, [ISBN: 9780470049662].
This module does not have any article/paper resources
Other Resources
 
Module Delivered in
Programme Code Programme Semester Delivery
CR_ERNPI_9 Master of Science in Regulated New Product Introduction & Technology Transfer 1 Mandatory