SAFE08038 2019 Regulatory Affairs
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.
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 assignments will be available, subject to IT Sligo Procedure on late
submissions, 'Applications for extension of continuous assessment deadlines'.
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
|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
|Independent Learning||Not Specified||Self Study||4||Weekly||4.00|
Required & Recommended Book List
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.
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.
As directed in class.
Lecture Material, Research Reports and other relevant literature given in class.