REGU08005 2017 Risk Management and Design Control
Full Title
Risk Management and Design Control
Transcript Title
Risk Mgmt & Design Control
Code
REGU08005
Attendance
N/A %
Subject Area
REGU - Regulatory Affairs
Department
LIFE - Life Sciences
Level
08 - NFQ Level 8
Credit
05 - 05 Credits
Duration
Semester
Fee
€
Start Term
2017 - Full Academic Year 2017-18
End Term
9999 - The End of Time
Author(s)
Mary Butler
Programme Membership
SG_SMEDI_L08 201700 Higher Diploma in Science in Medical Device Regulatory Affairs and Quality
SG_SMEDI_L08 201700 Level 8 Certificate in Medical Device Regulatory Affairs and Quality
SG_SMEDI_E08 201700 Certificate in Medical Device Regulatory Affairs and Quality
SG_SMEDI_L08 201900 Higher Diploma in Science in Science in Medical Device Regulatory Affairs and Quality
SG_SMEDI_E08 201900 Certificate in Science in Medical Device Regulatory Affairs and Quality
SG_SMEDI_E08 202100 Certificate in Medical Device Regulatory Affairs and Quality
SG_SMEDI_L08 202100 Higher Diploma in Science in Medical Device Regulatory Affairs and Quality
Description
This module will enable students to understand the role of Risk assessment through the design process and product lifecycle.
Learning Outcomes
On completion of this module the learner will/should be able to;
1.
Analyse the concept of Risk Management
2.
Describe a basic Risk management system and its components
3.
Explain the application and requirements of Design & Risk Management under 21CFR 820
4.
Explain the application and requirements of Design & Risk Management under ISO14971
5.
Describe the risk management tools used to help manage risk in the product lifecycle
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.
Indicative Syllabus
The following is a summary of the main topics included in this particular module:
• Design Process Inputs
• Design Process Outputs
• Design Process Review
• Human Factors Engineering
• IS014971 -Risk Management Standard
• EU/US Risk Management Regulations
- Tools and Techniques for Risk Management
- The Product Lifecycle
Coursework & Assessment Breakdown
Coursework & Continuous Assessment
100 %
Coursework Assessment
| Title | Type | Form | Percent | Week | Learning Outcomes Assessed | |
|---|---|---|---|---|---|---|
| 1 | FMEA | Coursework Assessment | Written Report/Essay | 50 % | Week 3 | 3,4,5 |
| 2 | Online forums/Blogs | Coursework Assessment | Essay | 30 % | Week 6 | 2,3,4,5 |
| 3 | MCQ/LAQ | Coursework Assessment | Multiple Choice/Short Answer Test | 20 % | Week 10 | 1,2,3,4,5 |
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
2016-11-21 Strategy and Risk Management: An Integrated Practical Approach Wiley
ISBN 1940235219 ISBN-13 9781940235219
2016-11-21 Strategy and Risk Management: An Integrated Practical Approach Wiley
ISBN 1940235219 ISBN-13 9781940235219
Employees make dozens of day-to-day decisionsand any one of them could come back to haunt you, even when the decision does not seem to have hidden or unknown ramifications. That is why your organisation must have a protocol in place for identifying and mitigating all major business risks long before it is needed.
At the strategic level, risk management and strategic management are intertwined. Using this book, learn how to apply powerful tools and approaches to make your planning processes more effective and flexible and build a set of decision-making processes based on plain language. Author, Ron Rael, uses quality concepts/language (TQM & Six Sigma) to define the Enterprise Risk Management (ERM) process and value of prevention, while showing how these elements are both necessary and highly desired in an organisations strategic decision-making.
ERM extends to your everyday business decisions because employees take actions and make daily choices that could have a detrimental effect on your profits and businesss longevity and future. This book will
- provide a best practices view on the latest developments in ERM
- deliver how-to guidance on developing ERM processes at the enterprise and department levels
- facilitate enterprise-wide ERM participation via practical information and examples
- deliver cross-functional management and implementation of ERM
Module Resources
Non ISBN Literary Resources
as per booklist
URL Resources
Website: https://www.accessdata.fda.gov/scripts/c drh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.30
Website: https://www.iso.org/standard/38193.html