SAFE08038 2019 Regulatory Affairs

General Details

Full Title
Regulatory Affairs
Transcript Title
Regulatory Affairs
N/A %
Subject Area
SAFE - Safety Studies
ESCI - Environmental Science
08 - NFQ Level 8
05 - 05 Credits
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Edel Costello, Margaret McCallig
Programme Membership
SG_SOCCU_H08 201900 Bachelor of Science (Honours) in Science in Occupational Safety and Health SG_SOCCU_K08 201900 Level 8 Honours Degree Add-on in Science in Occupational Safety and Health

The aim of this module is to systematically explore the role of Regulatory Affairs in business management, covering Safe Product Design, Medical Device Directive, FDA regulations, GMP & CAPA, Machinery Directive & Food Safety Management Systems. 

Learning Outcomes

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


Examine the role of Regulatory Affairs in relevant industries from a product design, approval, process, liability and risk management perspective.


Recognise and apply the concepts of Good Manufacturing Practice (cGMP), Corrective and preventive action (CAPA) as applied to a regulated environment.


Examine product safety and regulatory requirements and develop a product liability prevention programme.


Analyse the requirements of the EU machinery directive, apply them to a machinery manufacturer and carry out relevant risk assessments.


Interpret and appraise Food Safety Standards in a manufacturing environment. 

Teaching and Learning Strategies

This module will be delivered fulltime. This will include lectures, group sessions, and site visits augmented by independent learning and directed learning. This approach is expected to address student learning needs. Moodle will be used as a repository of educational resources and as a means of assessment (e.g. quizzes, uploading assignments and journals).

Module Assessment Strategies

Module will be assessed by Continuous assessment (100%) Students will be assessed summatively through continuous assessment of group and individual work. Students will have opportunities to formatively assess their own knowledge through participation in class discussions and questions and answers sessions. Formative feedback will be given in class on an ongoing basis.

Repeat Assessments

Repeat assignments will be available, subject to IT Sligo Procedure on late
submissions, 'Applications for extension of continuous assessment deadlines'.

Module Dependencies


Indicative Syllabus

History and development of standards in relation to regulated environments

ISO 13485 QMS Medical Devices, FDA,  ISO 14971 Risk Management for Medical Devices; Product Liability Prevention Programmes.

Machinery Directive; Standards related to Machinery design, operation, control systems; self-certification for CE Marking

Elements of  management systems in relation to regulated environments; policy, planning, implementation, operation, performance measurement, product liability, consumer protection checking and corrective action, management review

Defining roles and assigning responsibilities in relation to Regulatory Affairs

The concept and management of Corrective and Preventive Actions (CAPA) in a regulated environment

Examine the interaction of Regulatory Affairs and Occupational Health & Safety management. 

BRC Global Standard on Food Safety;  the standardisation of quality, safety and operational criteria and assurance that manufacturers fulfil their legal obligations and provide protection for the end consumer. 

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
100 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 In-class discussions Formative Interview - % OnGoing 1,2,3,4,5
2 Group Project Project Assignment 40 % End of Semester 2,3
3 SAQ Continuous Assessment Closed Book Exam 20 % OnGoing 5
4 Individual Assignment Continuous Assessment Closed Book Exam 20 % End of Semester 4
5 Presentation Continuous Assessment Assignment 20 % OnGoing 1,2,3,4,5

Full Time Mode Workload

Type Location Description Hours Frequency Avg Workload
Lecture Flat Classroom Lecture 3 Weekly 3.00
Independent Learning Not Specified Self Study 4 Weekly 4.00
Total Full Time Average Weekly Learner Contact Time 3.00 Hours

Required & Recommended Book List

Required Reading
2017-07-17 The GMP Handbook Createspace Independent Publishing Platform
ISBN 1548370258 ISBN-13 9781548370251

CGMP, Current Good Manufacturing Practices has legal and practical implications for manufacturers of medicinal products and medical devices. The requirements to meet CGMP is legal requirement but it also ensures the patient receives products that are safe, effective and of consistent quality. The FDA, WHO, ICH, PIC/s AND Eudralex provide extensive guidance and regulations on many topics related to the manufacture of medicinal and drug products. A large body of reference materials is available to manufacturers and engineering professionals. This book brings together the key requirements of GMP and briefly examines the common themes and requirements published by the various authorities, bodies and international organisations. The book includes the following chapters: Chapter 1-Overview of Good Manufacturing Practices Chapter 2-Quality Management Chapter 3-Personnel Chapter 4-Buildings and Facilities Chapter 5-Process Equipment Chapter 6-Documentation and Records Chapter 7-Materials Management Chapter 8-Rejection and re-use of materials Chapter 9-Validation Chapter 10- Change Control Chapter 11-Complaints and recalls Page count 160. Paperback book. Large 8" x 10" format.

Module Resources

Non ISBN Literary Resources

Applicable EU Directives as detailed in lecture notes.

Irish Health and Safety Authority publications and Guidelines as detailed in lecture notes.

Guide to application of the Machinery Directive 2006/42/EC 

ISO Standards related to machinery safety as detailed in lecture notes. 

ISO 13485: Medical devices -- Quality management systems -- Requirements for regulatory purposes

ISO 14971: Medical devices -- Application of risk management to medical devices

BRC Global Standards publications, white papers and supplementary guidelines as detailed in lecture notes.


Journal Resources

As directed in class.

URL Resources 

Other Resources

Lecture Material, Research Reports and other relevant literature given in class. 

Additional Information