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Book of modulesMTQ2 - MTQ2 Certificate in Medical Technologies RegulatoryAffairs and Quality

6 modules listed.

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Course Stream MTQ2 - MTQ2 Certificate in Medical Technologies Regulatory Affairs and Quality · 24 August 2017

APPROVED

MTQ2 Certificate in Medical Technologies Regulatory Affairs and QualityAwards

No Programme Award Assigned

Course Stream Code: MTQ2

Mode of Delivery: Part Time

No. of Semesters : 2

NFQ Level: 8

EQF Level: 6

EHEA Level: First Cycle

Embedded Award: No

Course Stream Short Title: Certificate in MedTech Regulatory Affairs and Quality

Language of Instruction: English

Valid From: 2017-18 (01-09-17 – 31-08-18)

Course: Certificate in Medical Technologies Regulatory Affairs and Quality

Discipline: College of Science

Location: NUIG

Course Stream Director: TERRY SMITH

Educational Aim of Course Stream: n/a

Clearing House Code: GYS281.


Semester Schedules

Code: 1MTQ2 / Location: NUIG / 30 ECTS / Semester 1

Optional

Mod Code Module Title Co-ordinator Level ECTSCredits

FT ContactHours

PT ContactHours

WrittenAssessment

ContinuousAssessment

Oral, AudioVisual orPracticalAssessment

Department-basedAssessment

Research Study Abroad Computer-basedAssessment

MTR1101 Introduction toQualityManagementSystems(Approved)

8 5 0.00 1.42 0 100 0 0 0 0 0

MTR1102 Fundamentalsof EU MedicalDeviceRegulations(Approved)

8 5 0.00 1.42 0 100 0 0 0 0 0

MTR1103 Auditing andCompliance(Approved)

8 5 0.00 1.42 0 100 0 0 0 0 0


Code: 1MTQ2 / Location: NUIG / 30 ECTS / Semester 2

Optional

Mod Code Module Title Co-ordinator Level ECTSCredits

FT ContactHours

PT ContactHours

WrittenAssessment

ContinuousAssessment

Oral, AudioVisual orPracticalAssessment

Department-basedAssessment

Research Study Abroad Computer-basedAssessment

MTR1104 Fundamentalsof US MedicalDeviceRegulations(Approved)

8 5 0.00 1.42 0 100 0 0 0 0 0

MTR1105 RiskAssessment(Approved)

8 5 0.00 1.42 0 100 0 0 0 0 0

MTR1106 Validation andCalibration(Approved)

8 5 0.00 1.42 0 100 0 0 0 0 0

Year 1 Awards :

Certificate in Science in Medical Technology Regulatory Affairs and Quality


PO DeliveryNo Course Stream Outcomes Data has been attached to this Course Stream yet.


Who Can AccessStaff Member Staff Number

CORA COSTELLO 0023560S

CLAIRE MITCHELL 0023293S

TERRY SMITH 0060798S

Sheila Coyle 0023186S

Emer Toner 0001761S

SANDRA GANLY 0105689S

OLIVIA MC DERMOTT 0111815S

MTR1101: Introduction toQuality ManagementSystems( Semester:1 Optional )

Module Details

Title Short: Introduction to Quality Management Systems APPROVED


Module Code: MTR1101

ECTS Credits: 5

NFQ Level: 8

EQF Level: 6


Valid From: 2017-18 (01-09-17 – 31-08-18)

Teaching Period: Semester 1

Module Delivered in 1 programme(s)

Module Owner: TERRY SMITH

Module Discipline: NAT_SCI - School of Natural Sciences

Module Data: 1.7 - 2 LAB

Module Description: This module aims to provide students with an introduction to and understanding of setting up a basic QMSand its implementation. It also aims to provide the students with an understanding of the requirement for aquality management system and how to design this quality system under the CFR 820 or ISO13485headings.

Learning Outcomes

On successful completion of this module the learner will be able to:

LO1 Describe the evolution of Quality Management Systems

LO2 Describe a basic QMS and its components

LO3 Explain the application and requirements of a QMS as prescribed by 21CFR 820

LO4 Explain the application and requirements of a QMS as prescribed by ISO13485:2016

LO5 Describe the quality tools necessary to implement and achieve continuous quality improvement in the manufacturing

LO6 Illustrate the audit requirements of a QMS and how to deal with auditors


Module Content & Assessment

Indicative Content

No indicative content

No Written Assessment

Continuous Assessment

AssessmentType

AssessmentDescription

Outcomeaddressed

% oftotal

MarksOut of

PassMarks

Sitting AssessmentPeriod

AssessmentDate

Duration Mandatory

ContinuousAssessment1

Assignments,case studiesand writtenreviews

1,2,3,4,5,6 100.00 100 40 FirstSitting

Semester 1 n/a 0 True


Assignments,case studiesand writtenreviews

1,2,3,4,5,6 100.00 100 40 SecondSitting

Autumn n/a 0 True

No Oral, Audio Visual or Practical Assessment

No Department-based Assessment

No Research

No Study Abroad

No Computer-based Assessment

The institute reserves the right to alter the nature and timings of assessment


Module Workload

This module has no Full Time workload.

Workload: Part Time

Workload Type WorkLoad Description LearningOutcomes

Hours Frequency AverageWeeklyLearnerWorkload

Lecture Online lectures and tutorials 12 PerSemester

1.00

Independent & DirectedLearning (Non-contact)

Directed and self-directed learning 100 PerSemester

8.33

Lab Practical workshops 5 PerSemester

0.42

Total Hours 117.00

Total Weekly Learner Workload 9.75

Total Weekly Contact Hours 1.42

Module Resources

Recommended Book Resources

David L. Goetsch, University of West Florida and Oskaloosa-Walton 2016, Quality Management for Organizational Excellence, 8thEd., Pearson [ISBN: 9780133791853]

This module does not have any article/paper resources

Other Resources

Website: FDAWewbsite, FDAhttps://www.accessdata.fda.gov/scripts/c drh/cfdocs/cfCFR/CFRSearch.cfm

Website: ISO.orgwebsite, ISOhttps://www.iso.org/standard/36786.html

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfCFR/CFRSearch.cfm

https://www.iso.org/standard/36786.html

Module Full Time Equivalent


Discipline %

School of Natural Sciences 100

Module Delivered in

Course Stream Code Course Stream Title

MTQ2 MTQ2 Certificate in Medical Technologies Regulatory Affairs and Quality (Approved)

Module Instructors

Module Instructors

Staff Member Staff Email

OLIVIA MC DERMOTT [email protected]

MTR1102: Fundamentals ofEU Medical DeviceRegulations( Semester:1 Optional )

Module Details

Title Short: Fundamentals of EU Medical Device Regulations APPROVED



ECTS Credits: 5

NFQ Level: 8

EQF Level: 6


Valid From: 2017-18 (01-09-17 – 31-08-18)





Module Description: This module aims to provide students with an introduction to and a fundamental understanding of currentand upcoming EU legislation as it applies to medical devices and to provide students with an understandingof the EU classification system and potential regulatory pathways for placing medical devices on the marketin the EU. It also aims to provide the students with an understanding of the utilisation of standards andguidance documents (MEDDEVs, NBOGs and NBMEDS).

Learning Outcomes


LO1 Describe the evolution of current legislation and reasons for upcoming revised legislation

LO2 Classify a medical device under EU requirements

LO3 Analyse and navigate key guidance documents

LO4 Define an appropriate regulatory pathway for a number of device classifications and associated conformity assessmentroutes

LO5 Make change control assessments for common change types

LO6 Identify the key documents required in technical documentation to support an EU regulatory submission

LO7 Analyse the role and expectations of the manufacturer, authorized representative, notified body and Competent Authority

LO8 Describe the basics of ISO 13485:2016, PMS Requirements and Vigilance Requirements



Indicative Content




AssessmentType


Outcomeaddressed

% oftotal

MarksOut of

PassMarks


AssessmentDate

Duration Mandatory


Assignments 1,2,3,4,5,6,7,8 100.00 100 40 FirstSitting



Assignments 1,2,3,4,5,6,7,8 100.00 100 40 SecondSitting

Autumn n/a 0 True



No Research

No Study Abroad




Module Workload


Workload: Part Time




1.00

Independent Learning Directed and self-directed learning 100 PerSemester

8.33


0.42

Total Hours 117.00



Module Resources

This module does not have any book resources


Other Resources

Website: Irish Competent Authority (HPRA)website, Health Product Regulatory Authorityhttps://www.hpra.ie/homepage/medical-dev ices/regulatory-information

Website: European Medicines Agency (EMA)websitehttp://ec.europa.eu/growth/sectors/medic al-devices/index_en.htm

https://www.hpra.ie/homepage/medical-devices/regulatory-information

http://ec.europa.eu/growth/sectors/medical-devices/index_en.htm



Discipline %


Module Delivered in



Module Instructors

Module Instructors


No Teacher Staff Assigned

MTR1103: Auditing andCompliance( Semester:1 Optional )

Module Details

Title Short: Auditing and Compliance APPROVED



ECTS Credits: 5

NFQ Level: 8

EQF Level: 6


Valid From: 2017-18 (01-09-17 – 31-08-18)





Module Description: This module introduces the regulatory requirement for GMP & compliance auditing, its benefits to anorganisation and the tools required by an effective auditor. In addition, it also introduces corrective andpreventive action, non conformance reporting and ongoing compliance.

Learning Outcomes


LO1 Interpret and explain the relevance of auditing as a means of monitoring the production of safe and effective medtechproducts in a GMP environment

LO2 Describe the various auditing techniques available and the regulatory basis for GMP/compliance auditing

LO3 Source, interpret and apply GMP principles to different case scenarios

LO4 Roleplay and participate in a multidisciplinary team of auditors within a GMP environment

LO5 Critique the performance of a systematic and independent examination of the effectiveness of a quality system

LO6 Identify, assess and analyse breaches of GMP and recommend appropriate corrective and preventive actions

LO7 Evaluate non-conformance statements and understand the non conformance management process



Indicative Content




AssessmentType


Outcomeaddressed

% oftotal

MarksOut of

PassMarks


AssessmentDate

Duration Mandatory


Assignments 1,2,3,4,5,6,7 100.00 100 40 FirstSitting



Assignments 1,2,3,4,5,6,7 100.00 100 40 SecondSitting

Autumn n/a 0 True



No Research

No Study Abroad




Module Workload


Workload: Part Time




1.00



8.33


0.42

Total Hours 117.00



Module Resources


Carl T. DeMarco., Medical device design and regulation, Milwaukee, Wis; ASQ Quality Press [ISBN: 9780873898164]

Dennis.R.Arter 2002, Quality audits for improved performance, 3rd Ed., ASQ [ISBN: 978-0-87389-5]


This module does not have any other resources



Discipline %

Inter-Institutional 100

Module Delivered in



Module Instructors

Module Instructors



MTR1104: Fundamentals ofUS Medical DeviceRegulations( Semester:2 Optional )

Module Details

Title Short: Fundamentals of US Medical Device Regulations APPROVED



ECTS Credits: 5

NFQ Level: 8

EQF Level: 6


Valid From: 2017-18 (01-09-17 – 31-08-18)





Module Description: This module aims to provide students with an introduction to and a fundamental understanding of currentUS legislation as it applies to medical devices and to provide students with an understanding of the US FDAclassification system and potential regulatory pathways for placing medical devices on the market in the US.It also aims to provide the students with an understanding of the utilisation of standards and FDA guidancedocuments.

Learning Outcomes


LO1 Describe the evolution of current legislation

LO2 Classify a medical device under US requirements

LO3 Analyse and navigate key guidance documents and consensus standards and key FDA medical device databases

LO4 Define an appropriate regulatory pathway for a number of device classifications

LO5 Make change control assessments for common change types

LO6 Identify the key documents required in technical documentation to support a US regulatory submission

LO7 Evaluate how to interact effectively with FDA agents/reviewers

LO8 Evaluate the basics of US QSRs, PMS Requirements and Vigilance Requirements and navigate the US FDA MAUDEdatabase



Indicative Content




AssessmentType


Outcomeaddressed

% oftotal

MarksOut of

PassMarks


AssessmentDate

Duration Mandatory


Assignments 1,2,3,4,5,6,7,8 100.00 100 40 FirstSitting



Assignments 1,2,3,4,5,6,7,8 100.00 100 40 SecondSitting

Autumn n/a 0 True



No Research

No Study Abroad




Module Workload


Workload: Part Time




1.00



8.33


0.42

Total Hours 117.00



Module Resources


Mantus, Pisano 2014, FDA Regulatory Affairs, 3rd Ed., CRC Press [ISBN: 9781841849201]

Carl T. DeMarco., Medical device design and regulation, Milwaukee, Wis; ASQ Quality Press [ISBN: 9780873898164]





Discipline %


Module Delivered in



Module Instructors

Module Instructors



MTR1105: Risk Assessment( Semester:2 Optional )

Module Details

Title Short: Risk Assessment APPROVED



ECTS Credits: 5

NFQ Level: 8

EQF Level: 6


Valid From: 2017-18 (01-09-17 – 31-08-18)





Module Description: Understand the role of Risk assessment through the design process and product lifecycle. Understand theconcept of Risk Management and describe a basic Risk management system and its components as well asthe application and requirements of Design & Risk Management under 21CFR 820

Learning Outcomes


LO1 Analyse the concept of Risk Management

LO2 Describe a basic Risk management system and its components

LO3 Explain the application and requirements of Design & Risk Management under 21CFR 820

LO4 Explain the application and requirements of Design & Risk Management under ISO14971

LO5 Describe the risk management tools used to help manage risk in the product lifecycle



Indicative Content




AssessmentType


Outcomeaddressed

% oftotal

MarksOut of

PassMarks


AssessmentDate

Duration Mandatory


Assignments,case studiesand reviews

1,2,3,4,5 100.00 100 40 FirstSitting



Assignments,case studiesand reviews

1,2,3,4,5 100.00 100 40 SecondSitting

Autumn n/a 0 True



No Research

No Study Abroad




Module Workload


Workload: Part Time



Lecture Online lectures and tutorials 1,2,3,4,5 12 PerSemester

1.00



8.33


0.42

Total Hours 117.00



Module Resources


Ron Rael 2013, Strategy and Risk Management : An Integrated Practical Approach, 2nd Ed., John Wiley & Sons Inc. NC UnitedStates [ISBN: 9781940235219]


Other Resources

Website: FDAwebsite, FDAhttps://www.accessdata.fda.gov/scripts/c drh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.30

Website: ISOISO14971https://www.iso.org/standard/38193.html

https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.30

https://www.iso.org/standard/38193.html



Discipline %


Module Delivered in



Module Instructors

Module Instructors


OLIVIA MC DERMOTT [email protected]

MTR1106: Validation andCalibration( Semester:2 Optional )

Module Details

Title Short: Validation and Calibration APPROVED



ECTS Credits: 5

NFQ Level: 8

EQF Level: 6


Valid From: 2017-18 (01-09-17 – 31-08-18)





Module Description: This module introduces the regulatory requirement for calibration and validation within a GMP environment,their benefits to an organisation and the tools required for effective implementation This module will preparestudents to undertake different validation roles and will equip the student to complete many validationactivities within their organisation. The impetus for the development of this module has emerged fromindustry needs and the course content has been designed to meet this industry need. This module coversthe core aspects of interpreting and/or setting quality characteristics and their verification throughappropriate calibrated Inspection, Measurement and Testing processes. The module traces the metrologicalrequirements from quality characteristics through instrument selection, evaluation and on-going calibrationso that the student is fully aware of the purpose and operation of a good measurement managementsystem.

Learning Outcomes


LO1 Interpret and explain the relevance of calibration within a GMP and Quality Assurance environment.

LO2 Describe the various metrological requirements from quality characteristics through instrument selection, evaluation andongoing calibration

LO3 Outline the properties of a good measurement management system and how it links to validation

LO4 Interpret the key elements in a systematic approach to validation with an emphasis on medical device manufacture

LO5 Critique risk analysis and evaluation and how it relates validation 6. Source and interpret the industry standard guidelines inuse for validation within a GMP environment.

LO6 Source and interpret the industry standard guidelines in use for validation within a GMP environment.

LO7 Outline elements of validation documentation and understand the regulatory requirements and the use of risk managementtools in making regulatory decisions.



Indicative Content




AssessmentType


Outcomeaddressed

% oftotal

MarksOut of

PassMarks


AssessmentDate

Duration Mandatory


Assignments 1,2,3,4,5,6 100.00 100 40 FirstSitting



Assignments 1,2,3,4,5,6,7 100.00 100 40 SecondSitting

Autumn n/a 0 True



No Research

No Study Abroad




Module Workload


Workload: Part Time




1.00



8.33


0.42

Total Hours 117.00



Module Resources

This module does not have any book resources





Discipline %

Inter-Institutional 100

Module Delivered in



Module Instructors

Module Instructors



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