REGU08009 2021 Operations Management and GMP

General Details

Full Title
Operations Management and GMP
Transcript Title
Operations Management and GMP
N/A %
Subject Area
REGU - Regulatory Affairs
LIFE - Life Sciences
08 - NFQ Level 8
05 - 05 Credits
Start Term
2021 - Full Academic Year 2021-22
End Term
9999 - The End of Time
Mary Butler
Programme Membership
SG_SMEDI_L08 202100 Higher Diploma in Science in Medical Device Regulatory Affairs and Quality SG_SMEDO_E08 202100 Certificate in Science in Medical Device Regulatory Affairs and Operations

This module aims to provide students with an introduction to current and future knowledge of strategic operations including Industry 4.0, MedTech 4.0, and Smart Operations engineering and management in the context of a  GMP environment.

Learning Outcomes

On completion of this module the learner will/should be able to;


Debate Manufacturing & Operations Engineering functions and the importance of Operations Engineering Strategy in Product and Service design, Process Technology and Quality Control.


Recognise and Define GMP, Manufacturing types and layouts and describe how to balance a line


Explain Purchasing, Logistics, and Supply Chain Management concepts as well as Planning and Inventory control in the context of a GMP organization. 


Explain Industry 4.0 in the context of  MedTech 4.0;  definition, technologies, various Operations strategies in the context of a GMP organisation.


Summarise and explain Operational Excellence; Lean philosophy, Six Sigma; Agile Project Planning in the context of GMP Operations Management.


Illustrate data analytics; tools and techniques and calculations to demonstrate understanding and application of the learning outcomes.

Teaching and Learning Strategies

Content will be delivered primarily via online and blended methods. Additional lecturing, as required, may be provided by outside specialists and practitioners. Learning strategies including evidence based and enquiry based learning also will be used.  Resources used will include Moodle, Adobe connect, Panopto, and other multimedia such as youtube, webinars, literature databases.

Module Assessment Strategies

The assessment approach for this module will be 100% Continuous Assessment with a range of assessment methods employed including some of the following: short-form assessment exams incl. MCQ's, project assignments, group reports and essays and oral presentations.

Repeat Assessments

Repeat assignments will be given in line with Marks and standards

Indicative Syllabus

The following is a summary of the main topics included in this particular module: 

GMP manufacturing and operations engineering introduction and strategy, SPC, Quality planning and control in GMP environments. Product and service design. Process technology. Gmp facility layout and line balancing. Supply chain management and forecasting. Capacity planning and aggregate production planning. Inventory management and scheduling. Lean systems. Project planning and control. Enterprise resource planning (ERP).

This module aims to provide students with an introduction to current and future knowledge of strategic operations including Industry 4.0, MedTech 4.0, and Smart Operations engineering and management in the context of a  GMP environment.

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
100 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Technical report Continuous Assessment Written Report 20 % Week 3 1
2 Essay Continuous Assessment Essay 30 % Week 6 2,3,5
3 MCQ/LAQ Continuous Assessment Multiple Choice 15 % Week 10 4,5,6
4 Critical evaluation Continuous Assessment Written Report 25 % Week 8 4,6
5 Presentation Continuous Assessment Oral Exam 10 % Week 13 3

Online Learning Mode Workload

Type Location Description Hours Frequency Avg Workload
Online Lecture Online Lecture 2 Weekly 2.00
Independent Learning Online Independent Learning 5 Weekly 5.00
Total Online Learning Average Weekly Learner Contact Time 2.00 Hours

Required & Recommended Book List

Recommended Reading
2016-05-09 Global Logistics and Supply Chain Management Wiley
ISBN 1119117828 ISBN-13 9781119117827

Think of the many different products and services that are purchased and consumed each day how do they reach the end-user? What does this cost? What happens when something goes wrong?

Logistics and Supply Chain Management (SCM) are the areas of study which help us to explore and answer these questions. Today they play a very important role in underpinning the success of many organisations across the public and private sectors and impact how we live our lives. While the origins of logistics and SCM are firmly embedded in the manufacturing domain, the successful applications of logistics and SCM principles and practices are becoming increasingly relevant in the services area also see for example, the many changes that have recently been driven into healthcare systems and airlines.

Global Logistics and Supply Chain Management, now in its third edition, provides essential reading for anybody studying SCM and logistics. Encompassing both practical and strategic perspectives, it takes a truly global perspective, recognising the transnational nature of logistics activities in todays world.

Key features of this new and extended third edition include:

  • 18 up-to-date chapters on all aspects of logistics and SCM, including coverage of emerging and important topics such as security, technology and automation in logistics, supply chain data flows, logistics and the internet of everything, sustainability, supply chain vulnerability and trade facilitation.
  • New chapters include one on management science applications, which provides an easy and clear introduction to key quantitative techniques that can be applied to logistics and SCM.
  • 12 updated case studies, including new case studies on air cargo, portcity logistics, automobile manufacturing logistics and logistics infrastructure appraisal.

Module Resources

Non ISBN Literary Resources

As per booklist

URL Resources