REGU09006 2019 Quality Management System

General Details

Full Title
Quality Management System
Transcript Title
Quality Management System
Code
REGU09006
Attendance
N/A %
Subject Area
REGU - Regulatory Affairs
Department
LIFE - Life Sciences
Level
09 - NFQ Level 9
Credit
05 - 05 Credits
Duration
Semester
Fee
Start Term
2019 - Full Academic Year 2019-20
End Term
9999 - The End of Time
Author(s)
Mary Butler
Programme Membership
SG_SMEDI_M09 201900 Master of Science in Science in Medical Technology Regulatory Affairs SG_SMEDI_O09 201900 Postgraduate Diploma in Science in Science in Medical TechnologyRegulatory Affairs SG_SMEDI_E09 201900 Certificate in Science in Medical Technology Regulatory Affairs
Description

This module is taken by Level 9 students in Medical Technology Regulatory Affairs. It aims to provide students with a detailed knowledge and understanding of setting up a basic QMS and its implementation. It also aims to provide the students with a thorough understanding of the requirement for a quality management system and how to design this quality system under the CFR 820 or ISO13485 headings. It also aims to provide an overview of compliance assessment in relation to self assessment, external audits, vendor audits and demonstration of ongoing compliance, focusing on Part 11 compliance. The module is broken down as follows: ca 10% Intro/overview of QMS; 75% subsections of CFR 820; 15% Auditing and Part 11 compliance.

Learning Outcomes

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

1.

Demonstrate they have a detailed knowledge and understanding of how a medical device is designed and manufactured in line with 20 CFR Part 820 and ISO 13485

2.

Demonstrate and understand the basic overall principles of a QMS system

3.

Review the individual QMS system and understand in terms of management responsibility, auditing, supplier and vendor auditing, training, records, design control, production controls, statistical process control and corrective and preventative action (CAPA).

4.

Understand the role of QMS in terms of regulatory compliance and in achieving market authorisation.

5.

Critique and evaluate a QMS system (own organisation/other)

Teaching and Learning Strategies

The educational elements will be provided by the Institute of Technology Sligo, NUI Galway and NIBRT staff. Additional lecturing, as required, may be provided by outside specialists and practitioners. Online/blended programmes are designed for students who want to study part-time at a pace that matches their work-life balance. Through a combination of blended delivery formats including online (synchronous and asynchronous) as well as other technologies we strive to reach the forefront of emerging breakthroughs in the delivery and assessment of online students.

Module Assessment Strategies

The module will be assessed on the basis of 100% continuous assessment. Some or all of the following assessment modes may apply: examinations, practical work, projects, essays, vivas, seminars, and assignments. These assessments may be organised at different centres throughout the country and a selection of assignments may be assessed.

Sample Technologies in use during assessments
• Moodle
• Adobe connect
• Turnitin
• Panopto
• Microsoft office
• Multimedia including DVDs, webinars, youtube video clips, online videos

Repeat Assessments

The programme allows students to progress to a next stage if they have failed to attain the pass mark for a particular module. A student may be allowed to carry up to 10 credits into a new stage. This policy is at the discretion of the examination board.

Indicative Syllabus

The following is a summary of the main topics included in this particular module: CFR 820 or ISO13485. It also aims to provide an overview of compliance assessment in relation to self assessment, external audits, vendor audits and demonstration of ongoing compliance, focusing on Part 11 compliance. The module is broken down as follows: ca 10% Intro/overview of QMS; 75% subsections of CFR 820; 15% Auditing and Part 11 compliance.

Understand and evaluate the principle requirements underlying the
establishment and continuous monitoring of quality systems under ISO 13485
including but not exclusive to: Quality and resource Management, Product
Realization / Risk Management, Customer Related Processes, Design and
Development Process, Purchasing Process Product and Service Provisions,
Control of Monitoring and Measuring Devices, Feedback, Labeling
Requirements, Post Market Surveillance, Vigilance and Recall Processes and
Change Control.

Compile and recognise the importance of documentation as required by a quality system, paying particular attention to the quality manual, medical device master records, Standard operating procedures and Work instruction, batch records and process flows. Understand the review and release of documentation,archiving and destruction, retention requirements and essential elements of Good documentation practice.

Formulate and communicate a competency in statistical methods.

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
100 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Assignment written assignment Continuous Assessment Assignment 60 % Week 9 5
2 Case Study workshop scenarios (formative) Continuous Assessment Assessment 20 % Week 12 4,5
3 LAQ Continuous Assessment Open Book Exam 20 % Week 5 1,2,3,4

Part Time Mode Workload


Type Location Description Hours Frequency Avg Workload
Online Lecture Not Specified Lecture 2 Weekly 2.00
Total Part Time Average Weekly Learner Contact Time 2.00 Hours

Required & Recommended Book List

Recommended Reading
2011-04-07 Medical Device Design and Regulation Quality Press
ISBN 0873898168 ISBN-13 9780873898164

The intent of this book (MDDR, for short) is to present an introduction to, and overview of, the world of medical device regulation by the United States Food and Drug Administration (FDA), and the relationship of this regulatory scheme to the design and development of medical devices. In providing this information, the book covers the broad range of requirements, which are presented within eight major topics: background and regulatory environment, device design control, nonclinical testing, clinical testing, marketing applications, post-market requirements, quality systems/GMPs, and compliance/enforcement. This book provides students and professionals in the medical device industry with a road map to the regulation of medical devices. It provides a broad understanding of the breadth and depth of medical device regulation by collecting in one textbook coverage of the regulatory scheme for medical devices in terms that are suitable for engineers, scientists, and healthcare providers. The vast amount of information available on the subject is distilled into a concise and coherent presentation. There also are problems and projects at the end of each chapter. In addition to the usual questions requiring specific answers, the projects include the drafting of a device control plan, the development of a nonclinical test procedure, the resolution of a recall, the response to a Warning Letter, and the creation of a CAPA for a device deficiency. A solutions manual for these exercises is available to teachers who adopt the textbook for classroom use. Medical Device Design and Regulation (MDDR) also makes available over 100 complimentary live hyperlinks to web pages with additional relevant information, and offers users the opportunity to join and participate in the MDDR Users Group on LinkedIn.

Module Resources

Non ISBN Literary Resources
Carl T. DeMarco 2011 Medical Device Design and Regulation Quality Press
ISBN-10 0873898168 ISBN-13 9780873898164
Journal Resources
Carl T. DeMarco 2011 Medical Device Design and Regulation Quality Press
ISBN-10 0873898168 ISBN-13 9780873898164
URL Resources
Carl T. DeMarco 2011 Medical Device Design and Regulation Quality Press
ISBN-10 0873898168 ISBN-13 9780873898164
Other Resources

None

Additional Information

None