Understanding and Application of the OECD Principles of ...
6
www.glceurope.com Online MasterClass 16-18 November 2021 Hedwig Beernaert Understanding and Application of the OECD Principles of Good Laboratory Practices (GLP) MasterClass KEY TAKEAWAYS • Understanding of the OECD Principles of GLP in order to implement and to follow-up it correctly and completely • Learning how to define responsibilities • Learning how to organize trainings and evaluate results of training • Learning how to set-up study plans • Learning how to set-up Standard Operating Procedures (SOPs) • Learning how to set-up FORMs • Learning how to assure data integrity • Learning how to register and archive data • Learning how to organize and evaluate Quality Assurance Program
Transcript of Understanding and Application of the OECD Principles of ...
www.glceurope.com
Online MasterClass 16-18 November 2021
Hedwig Beernaert
Understanding and Application of the OECD Principles of Good Laboratory Practices (GLP)MasterClass
key takeaways
• UnderstandingoftheOECDPrinciplesofGLPinordertoimplementandtofollow-upitcorrectlyandcompletely• Learninghowtodefineresponsibilities• Learninghowtoorganizetrainingsandevaluateresultsoftraining• Learninghowtoset-upstudyplans• Learninghowtoset-upStandardOperatingProcedures(SOPs)• Learninghowtoset-upFORMs• Learninghowtoassuredataintegrity• Learninghowtoregisterandarchivedata• LearninghowtoorganizeandevaluateQualityAssuranceProgram
[email protected] +36 1 848 0515www.glceurope.com
16-18 November, 2021 Online MasterClass
Understanding and Application of the OECD Principles of Good Laboratory Practices (GLP) MasterClass
Theunderstanding,development, implementation, follow-upand improvementofthe
GLPPrinciplesisfundamentalfortheapplicationofnon-clinicalhealthandenvironmental
safetystudies.TheGLPPrinciplesaremandatoryfornon-clinicalsafetytestingoftest
items in pharmaceutical products, pesticide products, cosmetic products, veterinary
drugs as well as food additives, feed additives, and industrial chemicals and other
productsasrequiredbynationalregulationorlegislation.
Beforesetting-upaqualitysystemitisrecommendedthatorganizationsareperforming
are-engineeringprocessincludingthefollowingaspects:
• ASIS:Scope,Clients,Personnel,Apparatus,Infrastructure
• YOBE:Whichqualitysystem(s)shouldbeapplied?
• Marketingstudy:Whoarethepotentialcustomers?
• Vision:WhichapplicationswillbeGLPandnon-GLP?
• Policy:Whatarethestrategicandoperationalobjectives?
Alotofactors(sponsors,management,studydirectors,studypersonnel,qualityassurance
staffandarchivists)areinvolvedinthedevelopment,implementationandfollow-upofa
GLPqualitysystem.Therefore,correctunderstandingandinterpretationofthecontentof
theprinciplesofGLPandrelateddocumentsarecrucialbeforereliabledataareproduced
withthepurposetoregisterorlicensethetestitemsofdifferentorigin.
TheprogrammeofthisGLPtrainingcoursewillbefocussedto
• IntroductiontotheOECD(OrganisationforEconomicCo-operationand
Development)PrinciplesofGLP
• Managementresponsibilities
• PerformanceandreportingofGLPstudies
• QualityAssuranceProgram
TheorganizationofthisGLPTrainingCourseexistsofpresentations,questionsandanswers.
TheGLPworkshopisanadvancedGLPtrainingcoursewhereitisrecommendedthat
participantshaveabasicknowledgeandexperienceof theOECDGLPPrinciples to
followsuccessfullythistrainingcourse.
IntroductIon
[email protected] +36 1 848 0515www.glceurope.com
16-18 November, 2021 Online MasterClass
Understanding and Application of the OECD Principles of Good Laboratory Practices (GLP) MasterClass
Who should attend?
• Managementoftheorganization
• Studydirectors
• Scientists
• Technicalstaff
• QualityAssuranceManagers
• Archivists
• RepresentativesofGLPMonitoringandRegulatoryAuthorities
• TestFacilityManagement
• TestSiteManagement
• PrincipalInvestigators
• ITpersonnel
• Suppliersofapparatusandmaterials
1967: Master in chemical sciences (university Ghent)
1968-1980: Research fellow at the Scientific Institute of Public Health (Sciensano)
1980-1990: Head of the Food Section at the Institute
1990: Master in Business Administration (MBA) (University Brussels)
1990-2009: QA Manager of the Scientific Institute
1992-2008: Vice-President Accreditation Body BELAC (assessor)
1992-2009: Belgian representative at the EU and OECD GLP Working group
2009-current: General Manager EuroQAM Ltd (consultancy – training quality systems
GLP and ISO 17025)
Invited Professor at the Catholic University of Leuven and University Ghent for post-
doctorates (GLP Principles)
Referee of peer-review articles in scientific journals
Trainer:
Hedwig Beernaert
[email protected] +36 1 848 0515www.glceurope.com
16-18 November, 2021 Online MasterClass
Understanding and Application of the OECD Principles of Good Laboratory Practices (GLP) MasterClass
All dates and times are expressed in UTC/GMT+2 on the Agenda (CET Time Zone)
day1 day2
CoffeeBreak10:30 CoffeeBreak10:15
CoffeeBreak14:30
CoffeeBreak14:45
CoffeeBreak16:15
CoffeeBreak16:15
LunchBreak12:15
LunchBreak12:15
END Endofday117:15
END Endofday217:15
09:00 09:00
10:45 10:45
13:15
15:00
16:30
13:15
14:45
16:30
Introduction• Purposeofthetraining• HistoryoftheGLPPrinciples• Definitions• Scope• Areaofexpertise• GLPDocuments• MADdecision• GLPProcess
Facilities• Structureandproperties• Floorplan• Typeofrooms• Requiredinformation• SOPs• Security• Wastedisposal• Housekeeping
Organization and responsibilities • PolicyStatement• Organizationstructure• MasterscheduleofGLPandnon-GLPstudies• RolesandresponsibilitiesofSponsor• RolesandresponsibilitiesofTestFacilityManagement• RolesandresponsibilitiesofStudyDirector• Rolesandresponsibilitiesoftechnicalstaff• Rolesandresponsibilitiesofarchivist• Jobdescription• Trainingofstaff
Apparatus, materials and reagents • Listofapparatus• SOPs• Technicalinformation(FORM)• Requirements• Calibration–Validation–Maintenance• Labellingofapparatus,materialsandreagents• Computerizedsystems
Performance of a study • SOP• Structurestudyplan• Contentstudyplan• TestSystems• Experimentaldesign• Conduct
Test systems • Types• SOPs• Biologicalsystems• Fieldstudies• Short-termstudies
Questions and answers
Standard Operating procedures (SOPs)• Historicallist• Model• Approval• Review• Distribution• Recuperation• Archiving
Archiving• Responsibilities• SOPavailable• Manueland/orelectronic• Whatshouldberetained• Period• Requirements• Indexsystem• Facilities
Questions and answers
08:50 08:50 ConnectingtotheonlineMasterClass ConnectingtotheonlineMasterClass
[email protected] +36 1 848 0515www.glceurope.com
16-18 November, 2021 Online MasterClass
Understanding and Application of the OECD Principles of Good Laboratory Practices (GLP) MasterClass
All dates and times are expressed in UTC/GMT+2 on the Agenda (CET Time Zone)
day3
CoffeeBreak10:15
CoffeeBreak14:30
CoffeeBreak16:00
LunchBreak12:15
END Endofday317:15
09:00
10:30
13:15
14:45
16:15
17:05
Test items
• Definition• Responsibilities• Transportandreception• Handlingandstorage• Characterization• Characterization• Expirydate• Administration• Archiving• Disposal
Reporting
• Generalaspects• SOPs• Content• Dataintegrity
Quality Assurance Program
• Elements• SOP• Qualification• Independency• Rolesandresponsibilities• Inspections• QAStatement
Application pitfalls
Questions and answers
Feedback/Evaluation session
08:50 ConnectingtotheonlineMasterClass
[email protected] +36 1 848 0515www.glceurope.com
Upcoming Events
FINANCIAL EVENTS
• Fraud Preven� on, Detec� on and Inves� ga� on MasterClass
• Eff ec� ve Remote Internal Audi� ng MasterClass
• Facing Risks in Business MasterClass
• Fixed Income Por� olio Management MasterClass
• The Future of Internal Audit MasterClass
• Advanced Enterprise Risk Management MasterClass
September, 2021
September, 2021
September, 2021
October, 2021
October, 2021
November, 2021
August, 2021
August, 2021
August, 2021
September, 2021
September, 2021
September, 2021
September, 2021
September, 2021
September, 2021
September, 2021
September, 2021
September, 2021
September, 2021
September, 2021
September, 2021
October, 2021
October, 2021
October, 2021
October, 2021
October, 2021
October, 2021
November 2021
August, 2021
September, 2021
September, 2021
PHARMACEUTICAL EVENTS• Analysing and Dra� ing Commercial Contracts in Life
Sciences MasterClass
• VBA & Innova� ve Contrac� ng in Pharma MasterClass
• Pharma Contract Dra� ing MasterClass
• A Stakeholder Engagement Approach to Clinical Trials
MasterClass
• Pharma Mergers and Acquisi� ons MasterClass
• Advanced Precision Medicine MasterClass
• Pharmacovigilance on the Internet and Social Media
MasterClass
• Advanced CMC MasterClass
• How to Submit Varia� ons in Europe MasterClass
• Advanced Pharma Root Cause Analysis MasterClass
• Blockchain in Pharmaceu� cals Masterclass
• Unlocking the Poten� al of Cell and Gene Therapies
MasterClass
• Cri� cal Quality A� ributes of Recombinant Proteins
for Therapeu� c Use MasterClass
• Building Digital Health Solu� ons MasterClass
• Mee� ng the In Vitro Medical Devices Regula� on
MasterClass
• Advanced Nanotechnology in Medicine MasterClass
• Advanced Genome Edi� ng MasterClass
• US Healthcare & Smart Pharma Packaging –
Regula� ons & Technical MasterClass
• Synthe� c biology & Biopharma – a unique pla� orm
for growth and sustainable future MasterClass
• Risk Based Monitoring - During & Beyond Covid
MasterClass
• Advanced CMC MasterClass for the US Market
• Advanced CMC MasterClass + How to Submit
Varia� ons in Europe MasterClass
HUMAN RESOURCES EVENTS • Digitaliza� on Compensa� on & Benefi t Processes MasterClass
• Manage the Annual Salary Review MasterClass
CROSS INDUSTRY EVENTS • H&S Legal Compliance and Leadership MasterClass
About GLC
Global Leading Conferences (GLC) is an industry leader in the field of business intelligence. We provide interactive & impactful business platforms and networking opportunities for senior level executives by bringing them together for B2B Conferences, Global Summits, Training & Workshops. Being customer focused and having our client’s priorities at the forefront, are amongst our core values and is of high importance to the way we operate our business.Our passion for customer satisfaction and results, drive us to work with industry experts closely - who fully understand their peers interests and day-to-day challenges - in order to deliver the most impactful events. We are specialized in industries such as; Pharmaceutical, Banking & Finance, Energy, Oil & Gas, IT & Communication, Sales & Marketing, Law and Human Resources.Our commitment is to deliver the latest information to our clients, while maintaining highest quality and standards. By attending GLC events your company will be able to apply advanced strategies to your operations, gain the latest know-how’s and benchmark yourself higher against the competition while enjoying a 5 star environment.
Bring the most experienced industry leaders and professionals right into your company.
Maximize the learning possibilities by providing your employees unique learning experience without being out of office for several days. Our In-House trainings are customized to your needs and focused on specific issues your employees
need to understand and solve.
Contact us for more information and request your custom-made
In-House training.
GLC’s Custom In-House TraInIngs
16-18 November, 2021 Online MasterClass
Understanding and Application of the OECD Principles of Good Laboratory Practices (GLP) MasterClass
![oecd best practice principles on stakeholder …€¦ · Web viewIntroduction The draft OECD Best Practice Principles on Stakeholder Engagement in Regulatory Policy [the Principles]](https://static.fdocuments.net/doc/165x107/5f035bea7e708231d408d2d8/oecd-best-practice-principles-on-stakeholder-web-view-introduction-the-draft-oecd.jpg)
