nsf-dba medical device diploma€¦ · nsf-dba medical device ... and effective thinking in qa/ra...

NSF-DBA Medical Device DiplomaLearning through doing with experts at your side

Modules 1 to 8

Prospectus

The Georgian House, 22-24 West End, Kirkbymoorside, York, UK, YO62 6AF

The Diploma offers eight core modules to provide the modern Quality Assurance and Regulatory Affairs (QA/RA) professional with the knowledge, tools and techniques needed to manage the many aspects of worldwide medical device quality management and regulatory affairs.

The Benefits of the Diploma to you are: • Integratedworkbasedprojectsandassignments

• AccesstoadedicatedQA/RAtutor

• Practical,challengingandinnovativeworkbooklearningmethods

• Accreditationofpriorlearningforthosewhohavepreviouslystudiedrecognisedandrelevantcoursecontent

• Up-to-dateapplicationofthemostcurrentandeffectivethinkinginQA/RAformedicaldevices

• Aformalcertificateidentifyingyourachievements

• Excellentprofessionalrecognition

Thediplomautilisestheverylatestblendedlearningmethodstomaximizeyourlearningexperiencebyensuringthatthecourse materials match different learning styles.

TheDiplomawillchallengeyou,whichwillresultinyoubecomingmoreconfident,incontrolofyourcareerdevelopmentand vitally fully competent, throughout the world of medical devices.

The Diploma Core Modules are:

Module 1 Medical Device Regulatory Frameworks

Module 2 MedicalDeviceRiskManagementDesignDevelopmentandProductValidation

Module 3 Medical Device Clinical Evaluation

Module 4 MedicalDeviceConformityAssessment–PreparingandManagingTechnicalDocumentation

Module 5 MedicalDeviceConformityAssessment–ImplementingandManagingQualityManagement SystemProcesses

Module 6 MedicalDevicePost-MarketSurveillanceandVigilance

Module 7 WorkingwithCompetentAuthorities,NotifiedBodiesandotherRegulatoryStakeholders

Module 8 ManagementandBehaviouralSkillsinQualityAssuranceandRegulatoryAffairs

NSF-DBADiploma–Introduction

Tel: +44 (0) 1751 432999

Fax: +44 (0) 1751 432450

Email: [email protected]

Web: www.nsf-dba.com

Module Aims

To provide an overview of the current medical device regulatory landscape.

To provide a focus on the current international regulatory frameworks and similarities and differences by region, product and technology.

Provide tools for you to determine the necessary regulations, interactions and decisions when dealing with various types, technologies and features of medical devices including Diagnostic, Implantable, Drug-Device and emerging technologies.

Provide the techniques applied by expert regulatory professionals for managing classification, conformity assessment and the important strategic regulatory affairs for any product to market process.

Module 1

Medical Device Regulatory Frameworks

For more information on this module please call us on +44 (0) 1751

ScopeSpecificallyaimedtowardsallexecutives,designers,regulatory and quality professionals involved with theprojectmanagementofmedicaldevice market approval.

Course Content •Internationalregulatorymedicaldevice

frameworks

•Conceptsofamedicaldeviceincludingitsdefinition

•Characteristicsandregulatoryoversight

•Worldwideregulatorybodydepartments;theirstructure, functions and responsibilities

•Medicaldeviceclassification

•Conformityassessmentroutes

•Pre-marketapprovalprocessesandregulatoryrequirements

•Documentationrequirementsincludingapplications, registrations and technical evaluation documentation

•Lessonslearnedfromthepast;thedo’sanddon’tsofregulatorystrategy

•Interactingregulationsincludinganimaltissues, human tissues and blood plasma, PPE,machinerydirectivesandpharmaceuticaldirectives

•Scientificopinions,governmentactionsandindustrial lobbying

•Managingprivatelabelsandvirtualmanufacturing

•Communicationdocumentationandperformance measures

•Stayingontopofregulatorydecisions,changesandscientificopinion

Student Learning Outcomes •Understandingthemedicaldeviceregulatoryframework

within the EU

•Classifyingdevicesincludingactiveimplantable,general and in-vitro diagnostics

•Understandingtheoptions(routes)forCEmarkingusingDirectives 90/385, 98/79 and 93/42EEC

•Understandingtheinteractionsbetweendirectivesand organisational processes

•Establishingsolutionstomeetessentialsafetyandperformance requirements of medical device directives and other directives associated with your devices

•Determiningandimplementingthedocumentationrequiredtodemonstrateyourdevices’conformityandyourorganisation’sabilitytoimplementrequiredprocesses

•Identifyingandunderstandingthelinksbetweenclinicalevaluation,riskmanagement,designverificationandvalidation and the information supplied to use the devices safely

•Producingregulatoryprojectplanstodemonstratetoyour organisation the steps required and key tasks to be undertaken to place a device into the market

•Understandingtheprocessforprivate/ownbrandlabelling

•Understandingtheselection,rolesandresponsibilitiesofanEU authorised representative

•Understandingtheessentialprocessesandtheir content required to meet the quality system elements of the directives

Business Performance Objectives •Reduceunnecessaryconsultancyfeesthrough

increased technical knowledge

•Reducetheriskofdelayduetoaninappropriate regulatory pathway

•Optimisethedocumentationprocess

•Reducethecostofregulatoryupdates

432 999, email [email protected] or visit www.nsf-dba.com

Module 2

Medical Device Risk Management Design DevelopmentandProductValidationModule Aims

To provide design and quality engineers with an understanding of the process of risk management and its interaction with the design and development activities of an organisation. The module will introduce you to the concepts and process required for managing risk in situations where you are not design responsible, but responsible for placing products on the market.

The module will provide you with an understanding of how to identify, interpret and integrate the use of essential safety and performance requirements and medical device industry standards.


ScopeAimed at all those involved with the product to market process, in particular product management, product design, quality assurance and regulatory affairs.

Course Content •Riskmanagementconceptswithin

medical devices

•Theproductdevelopmentprocess and regulation

•Buildinganoptimumdesignand development process

•Aspectsofthedesignanddevelopmentplan

•Understandingintendeduse,userrequirementsand performance claims

•Productspecificperformancestandards

•Riskmanagementindesignandtheirinteraction with essential requirements

•Creatingproductspecificationtestmethodsand performance criteria

•Designverificationandvalidationmethods

•Thedesignreviewprocess

•Thedesignhistoryfileconstruction,itsmanagement and control

•Buildingtechnicalfilesanddesigndossiers

•Auditingthedesignanddevelopmentprocess

•Designcontroldo’sanddon’ts

•Riskmanagementinthesupplychain

•Processriskmanagement

•Managingriskasanownbrandlabelandvirtual manufacturing

•Integratingariskmanagementprocesswithinyour organisation

Student Learning Outcomes •Whatagooddesignanddevelopmentprocessisandthe

documentation requirements

•Understandthetoolsandtechniquesoftheriskmanagement process and how to integrate within your organisation

•Understandtheroleofstandardsandwhattodotodemonstrate an appropriately validated product

•Gainaknowledgeofthetoolsandtechniquesusedtohelpamanagementteamdeterminethattheclinicalbenefitoutweighs the risk

Business Performance Objectives •Areducedmedicaldeviceriskprofile

•Ahigherlevelofconfidence;yourdevicemeetsallthelateststate of the art standards and regulations

•Areductioninthenumberofhoursspentansweringnotifiedbody technical queries and questions


Module 3

Medical Device Clinical Evaluation

Module Aims

To provide professionals responsible for design quality assurance and regulatory affairs with the fundamental understanding of clinical evaluation and performance evaluation. The module will enable the student to undertake clinical evaluation of the medical devices they manufacture. This module will enlighten the student by providing an overview of the structural elements associated with clinical evaluation standards and regulatory guidance.


ScopeAimed at all medical device professionals responsible for the clinical evaluation process and/orexecutingclinicalevaluationresponsibilities.

Course Content •Theneedforclinicalevaluation

•Clinicalevaluationguidelines

•Undertakingclinicalevaluationaspartofthedesign process

•Determiningthetypesofclinicalevaluationandunderstanding the costs implications andbenefits

•Scientific,regulatoryandclinicalbodiesusedwithin the clinical evaluation process

•Clinicalinvestigationplanning

•Dealingwithcompetentauthorities

•Preparingforclinicalstudy

•Datacollectionmethodsanddeterminingsignificantsamplesize

•Clinicalqualityassuranceandgoodclinicalinvestigation practice

•Whentodoaclinicalinvestigation

•Managingclinicalinvestigations

•Concludinginvestigationsandpreparingclinicalevaluation reports

•Literaturesearchingandsummarytechniques

•Buildingapost-marketclinicalfollow up process

•Maintainingaclinicalevaluationstrategythroughout the lifecycle of a medical device

•Assessmenttechniquesusedintheauditandregulatory review by competent authorities and notifiedbodies

Student Learning Outcomes •Understandtheneedforclinicalevaluation

•Understandthelateststandardsandguidelinesandregulatory authority interpretations

•Understandtheprocessfordeterminingtheneedforclinicalinvestigations;tobeabletowriteaclinicalinvestigationplan

•Understandthefundamentalconceptsformanagingaclinical investigation study

•Produceaclinicalinvestigationreportthataddressesthemost up-to-date requirements

Business Performance Objectives •Ahigherlevelofunderstandingofyourmedicaldeviceslevel

of performance

•Abletoaccessthemostup-to-dateinformationsupportingthe effectiveness of your device

•Increasedconfidencefromnotifiedbodiesandcompetentauthorities with respect to your clinical evaluation methods

•Enhanceyournewproductdevelopmentpipelinebyhavingsound data


Module 4

Medical Device Conformity Assessment–Preparingand Managing Technical Documentation


Module Aims

To give the medical devices professional a solid grounding in what is required for a regulatory submission relating to providing assurance of product safety. In addition this module aims to provide the student with the tools and techniques necessary to optimise the collection, interpretation, summary and distribution of technical data supporting medical device safety.

ScopeAimed at those who are involved in managing the submission ofdocumentationtocompetentauthorities,notifiedbodiesandother interested agencies.

Course Content •Typicaldocumentationrequiredbycompetentauthorities,

notifiedbodiesandotherinterestedagencies

•Managingtheinformationdistributedwithin your organisation

•Guidancedocumentsproducedbycompetentauthorities,notifiedbodiesandotherinterestedagenciesandthe EU commission

•Summarytechnicalevaluationdocumentation

•Utilisingsoftwaretoreduceduplicationandincreasethespeed of distribution and review

•Thecompetentauthorityreviewprocessesfor technical documentation

•Thenotifiedbodyreviewprocessesfor technical documentation

•Documentcontrolprinciples

•Managingchangesandsupplements

•Presentingdatanecessaryforcompliancewiththeessentialsafety and performance requirements

Student Learning Outcomes •Understandthetypicalformatsandrequirementsfor

regulatory documentation

•Understandthecontentandstructureof technical documentation

•Abletoinfluencetheirowninternaldepartmentstowardscreating a systematic method of documentation

•Identifythebenefitsassociatedwithutilising information technology

•Themethodsforwritingeffectivetechnicalsummaries

Business Performance Objectives •Reducingthenumberofiterationsof

documents issued to regulatory authorities

•Increasingthespeedofobtaining,compilingand distributing technical documentation to regulatory authorities reducing the duplication of work-effort

•Reducingthenumberofregulatoryfailuresassociated with technical documentation, accuracy and availability


Module 5

Medical Device Conformity Assessment–Implementingand Managing Quality ManagementSystemProcesses

ScopeThe module is aimed at professionals involved in qualitymanagementsystems’implementationwithin an organisation.

Course Content •Fundamentalsandconceptsofaprocess

•Typicalorganisationalprocessesinvolvedinmedicaldevice manufacturing

•Qualitymanagementsystemrequirements and documentation

•Designanddevelopmentprocesses

•Goodmanufacturingprocesseswithin medical devices

•Post-marketsurveillanceandvigilance

•Processvalidationrequirements

•Suppliercontrolprocesses

•Correctiveandpreventiveactionprocesses

•Processvalidation

•Resourcemanagement

•Supplycontrolprocesses

Student Learning Outcomes •Whattherequirementsareforimplementinga

quality management system within medical device regulations

Business Performance Objectives •Nosignificantregulatorycomplianceissues


Module Aims

To provide the student with an overview of the quality system management requirements necessary for the design, manufacture, use and post-market surveillance within medical device supply. The module will give the student an insight into the best practices adopted within these processes. It will also introduce the student to the conformity assessment annexes of the medical device directive and its interaction with international quality management systems standards.

Module 6

MedicalDevicePost-MarketSurveillanceandVigilance


Module Aims

To provide the student with an overview of the regulatory requirements for managing a medical device placed on the market. The module will provide the student with the current interpretation for post-market surveillance and vigilance and outline the links between QMS feedback, clinical follow up and vigilance decision making activities.

ScopeThe module is aimed at regulatory management professionals and quality management.

Course Content •Post-marketsurveillanceandvigilance

guidance documents

•Implementingfeedbacksystemswithin the organisation

•Creatingpost-marketsurveillanceplansforspecificproducttypes

•Understandingadverseevents

•Utilisingriskmanagementinadverseeventdecision making

•Creatingstatisticaltrendingsystemstodetect long term failures

•Managingrecalls

•Communicatingadverseeventstoregulatory authorities

•Managingmarketnotifications

Student Learning Outcomes •Understandtheframeworkforpost-marketsurveillanceand

vigilance activities

•Demonstratetheneedforpost-marketsurveillanceplansandidentifyproductspecificguidance

•Createapost-marketsurveillanceprocess

•Demonstratethebenefitsoflinkingqualitymanagement system feedback analysis of data, risk management and clinical evaluation

•Defineanadverseevent

Business Performance Objectives •Compliancewithregulatoryreportingcriteria


Module 7

Working with Competent Authorities, NotifiedBodiesandotherRegulatory Stakeholders


Module Aims

To provide the student with an understanding of the roles and responsibilities of the various regulatory and technical authorities involved in the medical device conformity assessment process. The module will provide an insight into the communication methods necessary in order to agree regulatory affairs strategy prior to and during the conformity assessment process. The module will provide the student with the knowledge of the specific product, regulation, technology specific organisations involved in the lobbying and interpretation of regulatory specific topics associated with medical devices.

ScopeThe module is aimed at personnel within the organisation involvedspecificallywithregulatoryaffairsstrategicplanning, for those who are required to update the organisation on current news events and interpretations and personnel involved in the conformity assessment process.

Course Content •StructureoftheEuropeanCommissionwithrespect

to medical devices

•Competentauthoritycommunicationprocessesandoverview of the capability costs and opportunities open for manufacturers

•Communicatingwithnotifiedbodies–determiningthe optimum time and forum

•Managingcommunicationbetweenmedicinesagencies, clinical trial sites, competent authorities andnotifiedbodies

•Identifyingandappointingscientifictechnicalandregulatoryexperts

•Joiningindustryandtradeassociations

•Creatingregulatoryintelligencenetworks and databases

Student Learning Outcomes •Understandthestructureandcommunication

methods of the various competent authorities, notifiedbodiesandotherregulatorystakeholders

•Identifywhenandhowtocommunicatewithcompetentauthorities,notifiedbodiesandotherregulatory stakeholders

•Joinandparticipateinindustryassociationsandtheirwork programmes

•Identifytherelevantpublicallyavailablesourcesof information and compile regulations updates for design quality, regulatory and management professionals within their own organisation

Business Performance Objectives •Speedtoreacttoaregulatorychangewillincrease

•Changestoregulatorystrategyintra-projectwilldecrease based upon enhanced knowledge prior to conformity assessment


Module 8

ManagementandBehaviouralSkills in Quality Assurance and Regulatory Affairs


Module Aims

To provide the student with the best practice human resource management tools and techniques that are required to competently lead and manage within a quality assurance and regulatory affairs environment. The module will also list the key behaviours needed for all quality assurance and regulatory affairs professionals to be effective within their role, along with best practice tools and techniques when demonstrating these behaviours.

ScopeThe module is aimed at personnel within a quality assurance and regulatory affairs environment.

Course Content and Student Learning Outcomes •Howtocreatepresentationsforusewithinquality

assurance and regulatory strategies

•Howtoeffectivelyengageandinfluencekeystakeholders by presentation within a quality assurance and regulatory affairs environment

•Howtoeffectivelyoperateandcommunicatewithinaquality assurance and regulatory affairs environment

•Budgetingwithinaqualityassuranceandregulatoryaffairs environment

•Howtoperformancemanagewithinaqualityassuranceand regulatory affairs environment

•Howtoeffectivelyleadpeoplewithinaqualityassurance and regulatory affairs environment

•Thebestpracticekeyperformanceindicatorsthatare commonly used within the quality assurance and regulatory affairs environment

•Howtoidentifycurrentlevelsofcompetencywithinaquality assurance and regulatory affairs environment

•Howtoidentifydevelopmentneedswithinaqualityassurance and regulatory affairs environment

•Howtoidentify,selectandmonitorexternalconsultants,notifiedbodiesandtrainingproviderswithin a quality assurance and regulatory affairs environment

•Howtoevaluateeffectivenessoftrainingwithinaquality assurance and regulatory affairs environment

•Presentingaconformityassessmentprocesswithinaprojectmanagementplan

•Typicalmeetings

Business Performance Objectives •Increasedperformancefromthequalityassurance

and regulatory affairs department

•Increasedlevelofcommunicationandlevel ofunderstandingfromprojectteamsand interacting departments


NSF-DBA Diploma

BlendedandSupportedLearning

For more information call us on +44 (0) 1751 432 999, email [email protected] or visit www.nsf-dba.com

Background

The NSF-DBA Diploma has been developed by experts from the fields of learning and development and uses the most up-to-date approaches to learning that are commonly used by many leading organisations across the world.

ProcessTheNSF-DBADiplomausesblendedlearningtechniquestoensurethatthelearner’sexperienceismaximised.TheapproachoftheNSF-DBADiplomasuitsalllearningstylesand will ensure that you will be effective in your learning when completing the Diploma.

Typical learning activities within the Diploma include:

•Workbooks

•Casestudies

•Exercises

•Knowledgetests

•Keylearningpoints

•Visualdiagramsofmodelsandflowcharts

•Podcasts

•Videoclips

•Onlinereferencelibrary

•Onlinetutorsupport

Benefits •YourlearningwillbemaximisedastheNSF-DBA

Diploma will include a variety of learning mediums and styles to suit all learning needs

•Alllearningcontentisavailableonlinethroughastudentportal and includes access to references, templates, case studies, podcasts and video resources

•Accesstoonlineandtelephonetutorsupportwhenyouneed it for your learning

Outcomes •Theapproachwillensurethatyouwilllearninthe

environment that most suits your needs

•Youwillfindlearningenjoyableas:

• No more boring presentations and sitting through lectures taking notes

•Nomorebeingtakenthroughexercisesthatare irrelevant to your product or technology

NSF-DBA Diploma

Written Assignments


Background

A key part of the Diploma is the written assignments; after each module you will be required to complete a written assignment for all eight modules. The assignments will allow you to practically apply the knowledge gained from your learning into your work.

ProcessAt the end of each module you will be provided with a range of questions where you can select the title of the assignment to match your learning needs or work interests.

TheNSF-DBAsubjectmatterexpertwill give you full support and give you comprehensive feedback on each assignment in the form of a detailed consulting report which you can utilise within your organisation.

Examples of assignments include:

•Communicatingwitha competent authority, determiningclassificationandconformity assessment route

•Creatingandimplementingarisk management process for your design department

•Managingavalidationprojectestablishing a validation protocol for a medical device process

•Creatingsupplierselectioncriteria and approving a sterilisation/packaging supplier

The written assignments will bethesameasexpectedwhenwriting a report for any medical device regulatory body, not exceeding3000wordsand will be in accordance with international education quality assurance standards.

Benefits •Successfulcompletionofassignmentsallowsyoutopracticallyapplythe

knowledge in the Diploma gained to a real scenario within the workplace

•Thisindustryleadinglearningapproachensuresexcellentprofessionaldevelopmentthroughmaximisingyourlearningexperience

•Youwillgainaccesstoamedicaldeviceexpertwithinthesubjectmatterarea

•Writtenassignmentmarkingisinaccordancewithinternationalqualityassurance standards to ensure your competence

•YouwillreceiveadetailedconsultingreportoneachwrittenassignmentfromanNSF-DBAexpertwhichyoucanutilisewithinyourorganisation

Outcomes •Youwillbeabletodemonstrateup-to-dateapplicationofthemostcurrent

and effective thinking in QA/RA for medical devices

•Youwilldemonstrateexcellentprofessionalrecognitionbysuccessfullycompleting each assignment

•Successfulcompletionofeachassignmentwillensureconfidencewithinyourrole and vitally ensure your competence within the world of medical devices

NSF-DBA Diploma

WorkBasedProject


Background

The work based project is a unique feature of the NSF-DBA Diploma where you are challenged to apply your learning in practice within your work.

ProcessYourworkbasedprojectwilldependuponwhatyouhavedoneinthepastas well as the challenges you face currently within your organisation. The workbasedprojectisusuallyrequiredtobesponsoredbyaseniormanagerwithin your organisation, although it is accepted that this may not be the case for all students.

Examples include:

•Managingtheregulatorysubmissionofanewmedicaldeviceinto the market

•Selectingasupplierforaprivatelabel

•Managingtheregulatorysubmission

•Managingamajorchangetoeitheradesignfeatureoranewmarket

•Ensuringallregulatoryandqualityaspectsarecovered

•Preparingandundertakingasignificantmedicaldeviceauditatacorporatelocation,supplieroronathirdpartybasis(notified body/mock audit)

Theworkbasedprojectwillbetypicalofascientific/technicalreportnotexceeding7500wordsandisinaccordancewithinternationaleducationqualityassurancestandards.ForeachworkbasedprojectyouwillbeassignedamentorfromtheNSF-DBADiplomateam.

Benefits •Successfulcompletionofaworkbased

projectwillallowyoutopracticallyapply the knowledge in the Diploma gained to a real scenario within the workplace

•Thisindustryleadinglearningapproachensuresexcellentprofessionaldevelopmentthroughmaximisingtheyourlearningexperience

•Youwillgainaccesstoamedicaldeviceexpertwithinthesubjectmatterarea

•Workbasedprojectmarkingisin accordance with international education quality assurance standards to ensure your competence

•YouwillreceiveacomprehensiveconsultingreportfromanNSF-DBAexpertonyourworkbasedprojectwhich will enable you to utilise within your organisation

Outcomes •Youwillbeabletodemonstrate

up-to-date application of the most current and effective thinking in QA/RA for medical devices

•Youwilldemonstrateexcellentprofessional recognition by successfully completingtheworkbasedproject

•SuccessfulcompletionoftheworkbasedprojectwillensureyouracquisitionoftheNSF-DBADiploma

•Successfulcompletionwillensureconfidencewithinyourroleandvitallyfully competent throughout the world of medical devices

NSF-DBA Diploma

AccreditationofPriorLearning(APL)


Background

When developing the Diploma it was important to us that the knowledge you have obtained and training you have already undertaken are used as a basis of the qualification. Therefore we have created a specific model for reviewing your in-house and external training to determine whether or not you qualify for exemptions to the modules.

ProcessWhen applying for the Diploma you will be required to identify any specifictrainingthatyoubelievemaysupportyourfundamentalknowledge of the learning outcomes. We will evaluate the courses in terms of content and contact you to determine your fundamental knowledgeandexperience.

Adatewillbebookedintoformallyreviewallofyourexemptionsandascertainwhichmodulesyouwillbeexemptfrom;thenyourtailoredDiploma will be processed and your assignments issued.

The assessment process for accreditation of prior learning is thorough and may sometimes require you to demonstrate your knowledge of various updates.

Typical examples for exemptions are as follows:

•MedicalDeviceDirectivethreedayexternaltrainingcoursedeliveredviaanotifiedbody

•InhouseMedicalDeviceGMP/ISO13485:2003auditcoursedeliveredbyaninternalexpert

Benefits •Youdonothavetostudyelements

in which you have already received foundation knowledge

•Youareabletodemonstrateyourknowledge through the assignments leading to faster completion of the module

•Previousinvestmentsintraininganddevelopment are taken into consideration

•Thefeesreducewitheachexemption

Outcomes •Aknowledgeoftheunitsyouwillneed

toundertakeandthosethatareexempt

•Formalrecognitionofthepreviousstudyyou have undertaken

The Georgian House, 22-24 West End, Kirkbymoorside, York, UK, YO62 6AF

Tel: +44 (0) 1751 432999

Fax: +44 (0) 1751 432450

MDPB2011

Email: [email protected]

Web: www.nsf-dba.com

nsf-dba medical device diploma€¦ · nsf-dba medical device ... and effective thinking in qa/ra...

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