Full Title Quality Management System

Short Title Quality Management System

Code REGU09006
Level 09
Credit 05

Author Butler, Mary
Department Life Sciences

Subject Area Regulatory Affairs
Attendence N/A%
Fee

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.

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.

Learning Outcomes
On completion of this module the learner will/should be able to
  1. Demonstrate they have detailed knowledge and understanding of how a medical device is designed, developed and manufactured in line with 20 CFR 820 and ISO13485.

  2. Source and interpret ISO13485, CFR 820 and various other relevant standards

  3. Understand and evaluate the key elements of 21 CFR 820 including but not
    exclusive to Quality Management System, Management responsibility, Resource Management,
    Product Realization, Measurement Analysis and Improvement .

  4. Demonstrate they have detailed knowledge and understanding of a QMS as specified by CFR820.

  5. Illustrate a thorough understanding of the underlying principles involved in regulatory compliance, the importance of auditing, best practice on dealing with auditors, Supplier and vendor approach, audit programme , preparation, audit management, dealing with regulatory agencies , audit response process, internal quality standards communication, effective line clearance, training, process flow charts, Part 11 compliance etc.

  6. Conduct a systematic and independent examination of the effectiveness of a quality system or of its parts. Demonstrate an awareness of the importance of auditor training and the internal auditing programme and how to deal with unannounced audits.

  7. Formulate and communicate an ability to implement quality and technical agreements.

  8. Communicate they have a detailed knowledge and understanding of the required actions to release product post regulatory approval.

  9. Demonstrate they have detailed knowledge and understanding of the regulatory role and requirements throughout the product development process.


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

Assessment Facilitites
Moodle access

Module Dependencies
Pre Requisite Modules
None
Co Requisite Modules
None
Incompatible Modules
None

Coursework Assessment Breakdown %
Course Work / Continuous Assessment 100 %

Coursework Assessment Breakdown

Description Outcome Assessed % of Total Assessment Week
Assignment written assignment 5,6,7 60 Week 9
Case Study workshop scenarios (formative) 4,5,6,7,8,9 20 Week 12
LAQ 1,2,3,4 20 Week 5


End Exam Assessment Breakdown

Description Outcome Assessed % of Total Assessment Week


Distance Learning Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload

Total Average Weekly Learner Workload 0.00 Hours

Part Time Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload
Online Lecture Not Specified Lecture 2 Weekly 2.00

Total Average Weekly Learner Workload 2.00 Hours

Full Time Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload

Total Average Weekly Learner Workload 0.00 Hours

Online Learning Mode Workload

Type Location Description Hours Frequency Avg Weekly Workload
Independent Learning Online Independent Learning 5 Weekly 5.00

Total Average Weekly Learner Workload 0.00 Hours

Resources
Book Resources

Other Resources
None
Url Resources
Additional Info

ISBN BookList

Book Cover Book Details
Carl T. DeMarco 2011 Medical Device Design and Regulation Quality Press
ISBN-10 0873898168 ISBN-13 9780873898164