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Increasing demand and the use of high-quality samples, data and services place biobanks at the center of basic and applied research. The BBMRI-ERIC Quality Management Service (BBMRI.QM) is designed to help biobanks and researchers meet the highest quality standards for their research and meet the needs of their clients. This webinar will give you an insight into the service portfolio of BBMRI.QM and an overview of relevant European and international standards useful for research on human specimens.

CORBEL (http://www.corbel-project.eu) is an initiative of eleven new biological and medical research infrastructures (BMS RIs), which together will create a platform for harmonised user access to biological and medical technologies, biological samples and data services required by cutting-edge biomedical research. CORBEL will boost the efficiency, productivity and impact of European biomedical research.

This webinar took place on 6th December 2018 and is part of the CORBEL webinar series. A recording of the webinar is available through the CORBEL website:
https://www.corbel-project.eu/webinars/bbmri-eric-quality-management-services.html

For previous and upcoming CORBEL webinars see:
http://www.corbel-project.eu/webinars

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CORBEL BBMRI-ERIC QM webinar slides

  1. 1. BBMRI-ERIC Quality Management Services for basic and applied research on human specimens Presenters: Andrea Wutte (BBMRI-ERIC) Host:Vera Matser (EMBL-EBI) 1 CORBEL Webinar Series
  2. 2. 2 This webinar is being recorded
  3. 3. AUDIENCE Q&A SESSION 3 Please write your questions in the questions window of the GoToWebinar application
  4. 4. BACKGROUND 4 Since 2015, thirteen ESFRI Research Infrastructures from the field of BioMedical Science (BMS RI) joined their scientific capabilities and services to transform the understanding of biological mechanisms and accelerate its translation into medical care. • biobanking & biomolecular resources • curated databases • marine model organisms • systems biology • translational research • functional genomics • screening & medicinal chemistry • microorganisms • clinical trials • structural biology • biological/medical imaging• plant phenotyping • highly pathogenic microorganisms
  5. 5. CORBEL MISSION 5 Modern biological and biomedical research involves complex projects and a variety of different technologies. Some of the most important discoveries are made at the interface between different disciplines. CORBEL will harmonise access and services for complex research projects involving more than one RI that offer: • biological and medical technologies • biological samples and • data services
  6. 6. TODAY’S PRESENTER 6 AndreaWutte has been leading the BBMRI-ERICQuality Management Service since 2014.The service includes Quality Management consultancy programmes for biobank relevant standards and guidelines, monitoring and audit programmes, training and education formats, assessments and the initiation of improvement strategies, respectively actions and accompanying measures. Andrea holds a European Quality Manager and Lead Auditor EOQ personnel certificate. She acts as BBMRI-ERIC LiaisonOfficer to ISO/TC 276 Biotechnology and ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems and CEN/TS 140 In vitro diagnostic medical devices. Andrea is a Biologist by training.
  7. 7. BBMRI-ERIC QUALITY MANAGEMENT SERVICES FOR BASIC AND APPLIED RESEARCH ON HUMAN SPECIMENS ANDREA WUTTE HEAD OF BBMRI-ERIC QM SERVICES AW, December 06, 2018 CORBEL webinar 1
  8. 8. 2 WE ARE Austria Bulgaria Belgium Czech Republic Estonia Finland France Germany Greece Italy Latvia Malta Netherlands Norway Poland Sweden United Kingdom MEMBERS Switzerland Cyprus Turkey IARC OBSERVERS AW, December 06, 2018 CORBEL webinar
  9. 9. THE WORLD‘S BIGGEST BIOBANK DIRECTORY
  10. 10. WHAT WE OFFER WITH ETHICAL, LEGAL AND SOCIETAL ISSUES SUPPORT AND EXPERTISE IT TOOLS MANAGEMENT SERVICES QUALITY 4AW, December 06, 2018 CORBEL webinar
  11. 11. QUALITY MANAGEMENT SERVICE “If we want researchers to be able to produce reliable findings, we need to make sure that they have access to samples and data of appropriate defined quality. As a European research infrastructure, our ultimate goal is to make samples comparable across different countries and different biobanking systems” 5AW, December 06, 2018 CORBEL webinar
  12. 12. BIOBANKS IN PERSONALIZED MEDICINE WORKFLOW BIOBANK QA/QC 6AW, December 06, 2018 CORBEL webinar
  13. 13. PARTNER CHARTER QM All Partners should commit themselves to implement quality management (QA / QC) procedures compliant with applicable European and International standards OECD Best Practice Guidelines for Global Biological Resource Centres Networks WHO/IARC Guidelines Common Minimum Technical Standards and Protocols for Biobanks dedicated to Cancer Research SOPs should be established and made publicly available for all processes related to sample collection, processing, storage, retrieval and dispatch. 7AW, December 06, 2018 CORBEL webinar
  14. 14. 8 BBMRI.QM NET Finland 11 Poland 4 Estonia 2 Austria 15 Czech Republic 2 Italy 9 Greece Turkey 5 Sweden 4 Norway 8 Germany 13 United Kingdom 7 Netherlands 1 Belgium 11 France 6 Switzerland 2 Malta 6 IARC 1 Cyprus Latvia 2 Bulgaria bbmri-eric.eu/national-nodes/ 109 Participants status 05.2018 AW, December 06, 2018 CORBEL webinar
  15. 15. BBMRI-ERIC QUALITY MANAGEMENT SERVICES International standards (ISO 9001, ISO 20387, ISO 15189, CEN Technical Specifications, etc.) Quality management in EU funded projects Quality management in national and international research projects ❖ Webinars, counseling International biobanking standards, Technical Specifications General quality management systems Integrated management systems Interface management systems ❖ Online training (Members) ❖ Inhouse training, Workshops ❖ Summerschools, Master courses FOR BASIC AND APPLIED RESEARCH BBMRI-ERIC Self- Assessment Survey for biobanks / researchers BBMRI-ERIC internal Audit KNOWLEDGE HUB TRAINING & SUPPORT AUDITING 9AW, December 06, 2018 CORBEL webinar
  16. 16. BBMRI.QM IN EU FUNDED PROJECTS SPIDIA for Personalized Medicine – Standardisation of generic Pre-analytical procedures for Invitro DIAgnostics for Personalized Medicine, SPIDIA4P ❖ Topic: SC1-HCO-02-2016 ❖ Grant agreement: 733112 ❖ Duration: 48 Month (2017-2021) ❖ Benefit/tasks for BBMRI- ERIC: standards to biobanks and reference centres, education and training programmes, industry-academia stakeholder workshop EXAMPLES SEE MORE http://www.bbmri-eric.eu/scientific-collaboration/ 10AW, December 06, 2018 CORBEL webinar
  17. 17. LIAISON TO ISO TECHNICAL COMMITTEES ISO/TC 276 “Biotechnology” -- ISO/TC 212 “Clinical laboratory testing and in vitro diagnostic test systems” -- CEN/TC 140 “In vitro diagnostic medical devices - European committees” ISO A GLOBAL NETWORK OF NATIONAL STANDARDS BODIES (160 MEMBERS) Reference: www.iso.org June 22, 2018 Medical Science Summer School, Groningen 11AW, November 29, 2018 How to build a Biobank – Course - Biobank Graz, Austria
  18. 18. ISO STANDARD FOR BIOBANKING ISO 20387:2018 A working Group within the ISO/TC 276 Biotechnology was established in December 2013 30 participating Member countries 14 Observer countries 7 Liaison organizations including BBMRI-ERIC More than 150 experts contributed to the development of: ISO 20387:2018 (E) Biotechnology -- Biobanking -- General requirements for biobanking 12AW, December 06, 2018 CORBEL webinar
  19. 19. 13 WHERE TO GET THE STANDARD? HTTPS://WWW.ISO.ORG/OBP/UI/#ISO:STD:ISO:20387:ED-1:V1:EN Reference: www.iso.orgAW, December 06, 2018 CORBEL webinar
  20. 20. ISO 20387:2018 TABLE OF CONTENT 1 Scope 2 Normative references 3 Terms and definitions 4 General requirements 5 Structural requirements 6 Resource requirements 7 Process requirements 8 Quality management system requirements Annex A (normative) Documentation requirements Annex B (informative) Implementation guidance for Annex A Annex C (informative) Quality management system options Bibliography Reference: www.iso.org14AW, December 06, 2018 CORBEL webinar
  21. 21. 15 ISO 20387:2018 3 Terms and definitions Examples::: 3.5 biobank Legal entity or part of a legal entity that performs biobanking(3.6) 3.6 biobanking Process of acquisition(3.2) and storing, together with some or all of the activities related to collection, preparation,preservation,testing, analyzingand distributingdefined biologicalmaterialas well as related information and data 3.7 biological material Any substance derived or part obtainedfrom an organic entity such as a human, animal, plant, microorganism(s) or multicellularorganism(s) that is (are) neither animalnor plant(e.g. brown seaweed, fungi) Reference: www.iso.orgAW, December 06, 2018 CORBEL webinar
  22. 22. ISO 20387:2018 SCOPE This document specifies general requirements including quality control requirements for the competence, impartiality and consistent operation of biobanks to ensure biological material and data collections of appropriate quality. This document is applicable to all organizations performing biobanking activities, including biobanking of human, animal, plant and microorganism resources for research and development. Biobank users, regulatory authorities, organizations and schemes using peer- assessment, accreditation bodies, and others can also use this document in confirming or recognizing the competence of biobanks. Reference: www.iso.org 16AW, December 06, 2018 CORBEL webinar
  23. 23. ISO 20387:2018 SCOPE This document does not apply to biological material intended for food production or therapeutic use. NOTE 1 International, national or regional regulations or requirements can also apply to specific topics covered in this document. NOTE 2 For entities handling human materials procured and used solely for diagnostic and treatment purposes ISO 15189 and other clinical standards apply first and foremost. Reference: www.iso.org 17AW, December 06, 2018 CORBEL webinar
  24. 24. ISO 20387:2018 TABLE OF CONTENT 4 General requirements 4.1 General 4.2 Impartiality 4.3 Confidentiality 5 Structural requirements 6 Resource requirements 6.1 General 6.2 Personnel 6.2.1 General 6.2.2 Competence and competence assessment 6.2.3 Training 6.3 Facilities/dedicated areas and environmental conditions 6.4 Externally provided processes, products and services 6.5 Equipment Reference: www.iso.org 18AW, December 06, 2018 CORBEL webinar
  25. 25. ISO 20387:2018 TABLE OF CONTENT Reference: www.iso.org 7 Process requirements 7.1 General 7.2 Collection of biological material and associated data 7.2.1 Documented information requirements 7.2.2 Pre-acquisition information 7.2.3 Collection procedure 🔎🔎 CEN/TS, ISO/TS pre-examination processes 7.3 Reception and distribution of biological material and associated data 7.3.1 Access principles 7.3.2 Reception 7.3.3 Distribution 7.4 Transport of biological material and associated data 19AW, December 06, 2018 CORBEL webinar
  26. 26. ISO 20387:2018 TABLE OF CONTENT Reference: www.iso.org 7.5 Traceability of biological material and associated data 7.6 Preparation and preservation of biological material 7.7 Storage of biological material 7.8 Quality control of biological material and associated data 7.8.1 General 7.8.2 Quality control of processes 7.8.3 Quality control of data 7.9 Validation and verification of method 7.9.1 General 7.9.2 Validation 7.9.3 Verification 7.10 Management of information and data 20AW, December 06, 2018 CORBEL webinar
  27. 27. ISO 20387:2018 TABLE OF CONTENT Reference: www.iso.org 7.11 Nonconforming output 7.11.1 General 7.11.2 Control of nonconforming output 7.12 Report requirements 7.12.1 General 7.12.2 Content of the report 7.13 Complaints 21AW, December 06, 2018 CORBEL webinar
  28. 28. ISO 20387:2018 TABLE OF CONTENT Reference: www.iso.org 8 Quality management system requirements 8.1 Options 8.1.1 General 8.1.2 Option A 8.1.3 Option B 8.2 Documented information for the quality management system (Option A) 8.3 Control of quality management system documents (Option A) 8.4 Control of records (Option A) 8.5 Actions to address risks and opportunities (Option A) 8.6 Improvement (Option A) 8.7 Corrective action for nonconforming output (Option A) 8.8 Internal audits (Option A) 8.9 Quality management reviews (Option A) 22AW, November 29, 2018 How to build a Biobank – Course - Biobank Graz, Austria
  29. 29. ISO 20387:2018 TABLE OF CONTENT Reference: www.iso.org 7 Process requirements 7.1 General 7.2 Collection of biological material and associated data 7.2.1 Documented information requirements 7.2.2 Pre-acquisition information 7.2.3 Collection procedure 🔎🔎 CEN/TS, ISO/TS pre-examination processes 23AW, November 29, 2018 How to build a Biobank – Course - Biobank Graz, Austria
  30. 30. May 24, 2018 MC&AoM meeting, Bologna 24 PRE-ANALYTICAL ERRORS “Pre-analyticalerrors still accountfor nearly 60% - 70% of all problems occurring in laboratorydiagnostics, most of them attributableto mishandlingprocedures during collection,handling,preparing or storing the specimens”. Lippi G. et al. Pre-analytical quality improvement:from dream to reality. Clin Chem Lab Med. 2011 Jul; 49(7):1113-26.
  31. 31. QUALITY OF SPECIMENS PUBLISHED COMPLAINTS Lippi G. et al. Preanalytical quality improvement: from dream to reality Clin Chem Lab Med. 2011 Jul; 49(7):1113-26.). Stephen A Bustin. The reproducibility of biomedical research: sleepers awake! Biomolecular Detection and Quantification 2014, pp. 35-42 Freedman LP et al. The Economics of Reproducibility in Preclinical Research. Plos Biol. 2015 Jun 9;13(6):e1002165. 25AW, December 06, 2018 CORBEL webinar
  32. 32. CEN TECHNICAL SPECIFICATIONS (CEN/TS) PRE-EXAMINATION PROCESSES / SAMPLE HANDLING PROCEDURES CEN/TS 16826-1, snap frozen tissue – Part 1: Isolated RNA CEN/TS 16826-2, snap frozen tissue – Part 2: Isolated proteins CEN/TS 16827-1, FFPE tissue – Part 1: Isolated RNA CEN/TS 16827-2, FFPE tissue – Part 2: Isolated proteins CEN/TS 16827-3, FFPE tissue – Part 3: Isolated DNA CEN/TS 16835-1, venous whole blood – Part 1: Isolated cellular RNA CEN/TS 16835-2, venous whole blood – Part 2: Isolated genomic DNA CEN/TS 16835-3, venous whole blood – Part 3: Isolated circ. cell-free DNA from plasma CEN/TS 16945 metabolomics in urine, serum and plasma cen.eu or bbmri-eric.eu 26AW, December 06, 2018 CORBEL webinar
  33. 33. NEW CEN/TS AND ISO STANDARDS IN THE PIPELINE UNTIL 2020 4 CEN/TS for venous whole blood circulating Tumor and Organ Cells (DNA, RNA, Proteins, staining procedures) 1 CEN/TS for Venous Whole Blood Exosomes / cell-free circulating RNA 1 CEN/TS for Saliva (DNA) 1 CEN/TS for Frozen Tissues (DNA) 1 CEN/TS for Urine and other body fluids (cell-free DNA) 3 CEN/TS for Fine Needle Aspirates (RNA, DNA, Proteins) 1 CEN/TS for Saliva and Stool Microbiomes (DNA) 1 CEN/TS for FFPE Tissues (in-situ staining procedures) H2020 ProjectSPIDIA4P,GANo. 733112 27AW, December 06, 2018 CORBEL webinar
  34. 34. CEN/TS “This Technical Specification gives recommendations for the handling, documentation and processing of xxx specimens intended for xxx analysis during the pre-analytical phase before a molecular assay is performed. This Technical Specification is applicable to molecular in vitro diagnostic examinations (e.g., in vitro diagnostic laboratories, laboratory customers, developers and manufacturers of in vitro diagnostics, institutions and commercial organizations performing biomedical research, biobanks, and regulatory authorities)“ Reference CEN/TS page 5, cen.eu SCOPE 28AW, December 06, 2018 CORBEL webinar
  35. 35. CEN/TS GENERAL CONTENTS Scope, Normative reference, Terms and definitions Outside the laboratory − Primary specimen collection manual, sample donor, sample processing, transport, Inside the laboratory − Sample reception, fixation, evaluation of the pathology, post fixation, processing of embedding, aliquoting, storage, isolation processes (RNA, DNA, Proteins..), using commercial kits, laboratories’ own protocols, Quantity and quality assessment, storage of isolated RNA, DNA, ccfDNA, Proteins.. Quality control of RNA, DNA, Proteins…, impact of preanalytical workflow steps on specimen quality, time dependencies of analyte integrity 29AW, December 06, 2018 CORBEL webinar
  36. 36. INTEGRATED MANAGEMENT SYSTEMS (IMS) QUALITY MANAGEMENT SYSTEMS - REQUIREMENTS ISO 9001:2015 COMBINES MULTIPLE MANAGEMENT SYSTEM STANDARDS IMS GENERAL REQUIREMENTS FOR BIOBANKING ISO 20387:2018 ISO 15189:2015 MEDICAL LABORATORIES REQUIREMENTS FOR QUALITY AND COMPETENCE 30
  37. 37. INCREASING THE VISIBILITY OF BIOBANKS AND SAMPLE COLLECTIONS 31AW, November 29, 2018 How to build a Biobank – Course - Biobank Graz, Austria
  38. 38. CEN/TS TO SELF-ASSESSMENT BBMRI-ERIC SELF-ASSESSMENT SURVEYS (IT-BASED) IT-based SAS 32AW, December 06, 2018 CORBEL webinar
  39. 39. ACCESS TO BBMRI-SAS WEBSITE www.bbmri-eric.eu/services/self-assessment-survey/ 33AW, December 06, 2018 CORBEL webinar
  40. 40. ASSESSMENT PROCESS 34 ACCESS COMPLETE SURVEY(S) REMOTE AUDIT REPORT SELF- ASSESSMENT granted by BBMRI-ERIC BBMRI-ERIC DIRECTORY ✓ AW, December 06, 2018 CORBEL webinar
  41. 41. REMOTE AUDIT independent evaluation based on self- assessment remote audit in cooperaton with trained auditor (e.g. TelCo, SkypeConf, etc.) triggered by SAS survey → report sent to BBMRI-ERIC support quality improvement by external expertise for biobankers and researchers − with and without ISO certification 35AW, December 06, 2018 CORBEL webinar
  42. 42. BBMRI-SAS TO DIRECTORY 36AW, December 06, 2018 CORBEL webinar
  43. 43. BBMRI-ERIC QUALITY MANAGEMENT SERVICES Principles of auditing Managing the audit Performing an audit Competence and evaluation of BBMRI auditors FOR BASIC AND APPLIED RESEARCH AUDITING 37AW, December 06, 2018 CORBEL webinar SERVICE 2019
  44. 44. CONTACT KNOWLEDGE HUB TRAINING & SUPPORT AUDITING 38 Co-funded within ADOPT BBMRI-ERIC, a project that has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 676550. Co-funded within SPIDIA4P, a project that has received funding from the European Union’s Horizon 2020 research and innovation programme under grant agreement No 733112. Andrea Wutte – andrea.wutte@bbmri-eric.eu http://www.bbmri-eric.eu/services/quality-management/
  45. 45. Questions? BBMRI-ERIC Quality Management Services for basic and applied research on human specimens AndreaWutte (BBMRI-ERIC)
  46. 46. MERRY CHRISTMAS footer We will be going on a winter break, the CORBEL webinar series will resume in January 2019 Registration and details http://www.corbel-project.eu/webinars

Increasing demand and the use of high-quality samples, data and services place biobanks at the center of basic and applied research. The BBMRI-ERIC Quality Management Service (BBMRI.QM) is designed to help biobanks and researchers meet the highest quality standards for their research and meet the needs of their clients. This webinar will give you an insight into the service portfolio of BBMRI.QM and an overview of relevant European and international standards useful for research on human specimens. CORBEL (http://www.corbel-project.eu) is an initiative of eleven new biological and medical research infrastructures (BMS RIs), which together will create a platform for harmonised user access to biological and medical technologies, biological samples and data services required by cutting-edge biomedical research. CORBEL will boost the efficiency, productivity and impact of European biomedical research. This webinar took place on 6th December 2018 and is part of the CORBEL webinar series. A recording of the webinar is available through the CORBEL website: https://www.corbel-project.eu/webinars/bbmri-eric-quality-management-services.html For previous and upcoming CORBEL webinars see: http://www.corbel-project.eu/webinars

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