This 3-sentence summary provides the key details about the document:
The document announces the upcoming "Quality in the Spotlight" conference in Antwerp, Belgium on March 14-15, 2016. The two-day conference will focus on pushing the envelope on quality issues in medical laboratories, including continuing discussions around establishing performance specifications from previous conferences in Stockholm and Milan. Speakers will address resolving debates around total analytic error versus measurement uncertainty and developing consensus on a comprehensive quality management model.
From Terminal Sterlization to Aseptic Manufacturing of Perentral Products: Gu...Obaid Ali / Roohi B. Obaid
This document provides an overview of terminal sterilization versus aseptic manufacturing of parenteral products. It discusses various challenges related to microorganisms like their ability to form spores, sensitivity to heat/radiation/chemicals, and whether they are aerobic/anaerobic. It notes that aseptic processing provides increased separation of personnel and confidence in sterility assurance compared to conventional methods. The document emphasizes taking a proactive approach to risk management and quality assurance to better understand processes and assure patient safety.
The document discusses the objectives and topics of a discussion forum on pharmaceutical engineering related to designing and maintenance of pharmaceutical manufacturing facilities. The main objectives are to provide an interface among multidisciplinary teams to discuss science and regulations in a common language, and to provide an opportunity for knowledge sharing and transfer among pharmaceutical professionals from different educational backgrounds. The forum will also serve as a platform for engineers to exchange knowledge and learn about expanding regulatory expectations. The opening talk will be given by the Deputy Director of the Drug Regulatory Authority of Pakistan and will focus on regulatory experience and knowledge sharing without obligation on the regulatory agency. Some of the specific topics to be discussed include design principles in relation to GMP standards, importance of cleaning and maintenance, facility layout designs
El documento presenta información sobre los sistemas operativos. Explica que un sistema operativo es el software que gestiona los procesos básicos de una computadora y permite ejecutar otros programas. Luego describe algunos sistemas operativos importantes como Windows, Macintosh y UNIX. Se enfoca específicamente en Windows, describiendo sus características como un entorno de escritorio intuitivo y multitarea, con elementos como el escritorio, ventanas, menú inicio, configuración y accesorios como Paint y Bloc de notas.
This document is a resume for Amr Mohyeldin Omran Elshennawy, an Egyptian mechanical engineer. It outlines his career history working as a mechanical engineer in Egypt since 2011, beginning as a rotating equipment engineer and progressing to maintenance section head at his current company. It also lists his education, skills, certificates, and interests.
Aula 07 da disciplina Organização, Métodos e Sistemas ministrada pelo Professor Euller Barros na Universidade de Brasília - UnB.
Conteúdo baseado no livro Criando Organizações Eficazes de Henry Mintzberg:
Estrutura Organizacional
+ Modelos Organizacionais
- Estrutura Simples
- Burocracia Mecanizada
- Burocracia Profissional
- Forma Divisionalizada
- Adhocracia
From Terminal Sterlization to Aseptic Manufacturing of Perentral Products: Gu...Obaid Ali / Roohi B. Obaid
This document provides an overview of terminal sterilization versus aseptic manufacturing of parenteral products. It discusses various challenges related to microorganisms like their ability to form spores, sensitivity to heat/radiation/chemicals, and whether they are aerobic/anaerobic. It notes that aseptic processing provides increased separation of personnel and confidence in sterility assurance compared to conventional methods. The document emphasizes taking a proactive approach to risk management and quality assurance to better understand processes and assure patient safety.
The document discusses the objectives and topics of a discussion forum on pharmaceutical engineering related to designing and maintenance of pharmaceutical manufacturing facilities. The main objectives are to provide an interface among multidisciplinary teams to discuss science and regulations in a common language, and to provide an opportunity for knowledge sharing and transfer among pharmaceutical professionals from different educational backgrounds. The forum will also serve as a platform for engineers to exchange knowledge and learn about expanding regulatory expectations. The opening talk will be given by the Deputy Director of the Drug Regulatory Authority of Pakistan and will focus on regulatory experience and knowledge sharing without obligation on the regulatory agency. Some of the specific topics to be discussed include design principles in relation to GMP standards, importance of cleaning and maintenance, facility layout designs
El documento presenta información sobre los sistemas operativos. Explica que un sistema operativo es el software que gestiona los procesos básicos de una computadora y permite ejecutar otros programas. Luego describe algunos sistemas operativos importantes como Windows, Macintosh y UNIX. Se enfoca específicamente en Windows, describiendo sus características como un entorno de escritorio intuitivo y multitarea, con elementos como el escritorio, ventanas, menú inicio, configuración y accesorios como Paint y Bloc de notas.
This document is a resume for Amr Mohyeldin Omran Elshennawy, an Egyptian mechanical engineer. It outlines his career history working as a mechanical engineer in Egypt since 2011, beginning as a rotating equipment engineer and progressing to maintenance section head at his current company. It also lists his education, skills, certificates, and interests.
Aula 07 da disciplina Organização, Métodos e Sistemas ministrada pelo Professor Euller Barros na Universidade de Brasília - UnB.
Conteúdo baseado no livro Criando Organizações Eficazes de Henry Mintzberg:
Estrutura Organizacional
+ Modelos Organizacionais
- Estrutura Simples
- Burocracia Mecanizada
- Burocracia Profissional
- Forma Divisionalizada
- Adhocracia
Analytical Science 5th Symposium Programme Registration Form (singlepages)?Graham Sithole?
The document is a program for the 5th Mintek Analytical Science Symposium taking place on October 30th, 2015 at Mintek in South Africa. The morning session will cover topics like celebrating 20 years of ISO17025 accreditation at Mintek and developments in guidance for using reference materials. The afternoon session will discuss root cause analysis, comparing analytical data from multiple laboratories, and applications of technologies like Fourier transform infrared spectroscopy.
2nd European Conference on Clinical ResearchMarket iT
The document provides information on the organizers, program committee, and agenda for the 2nd European Conference on Clinical Research being held from February 2-4, 2015 in Paris, France. The pre-conference on February 2nd will focus on how clinical procurement can provide strategic value beyond cost reductions. The main conference on February 3rd-4th will involve presentations and debates on key issues in clinical research regulation, new technologies, risk management, and the patient's role. Topics will include the impacts and challenges of the new EU Clinical Trials Regulation and new operational practices in clinical trials.
World ADC Frankfurt 2015 - sample brochureWorld ADC
The World ADC Frankfurt meeting has been established with the simple mission of speeding up the development of more potent and safe antibody drug conjugates.
Learn not only how to make an ADC, but how to make a great one. With insights on numerous novel payload technologies, robust strategies for preclinical evaluation and emerging clinical data, there is no better opportunity to accelerate your research.
POINT-of-IMPACT testing. A European perspective - Bert NiestersWAidid
This document discusses point-of-care and point-of-impact molecular diagnostic testing from a European perspective. It describes how molecular diagnostics is moving towards more commercial multiplex assays and automation. Near-patient testing provides results faster but challenges include defining quality indicators for new rapid assays and ensuring clinical relevance. Standards like ISO15189 and ISO22870 provide guidelines for quality control of centralized and decentralized testing. The changing regulatory landscape in Europe aims to improve safety and transparency for in vitro diagnostics.
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Pharma IQ brings you Clinical Trial Supply Europe Conference Profit. Successfully cutting costs and overages whilst increasing the flexibility and reactivity of your clinical supply network to support global clinical trials.
R3-Nordic, the Nordic Society of Cleanroom Technology, is a non-profit, independent association for the promotion of new technologies in cleanroom technology and contamination control in the Nordic countries. The aim of the annual R3Nordic Symposium is to provide knowledge within the pharmaceutical, food and electronic industries as well as hospitals and hospital pharmacies. This year the sessions at the 45th R3Nordic Symposium are Pharma, Hospital and General Sessions and the presentations deal with construction and design, planning, auditing, contamination control, cleanroom technology and management, sterilization techniques, cleaning of clean rooms, protective clothing, monitoring techniques, rapid test methods and regulations in clean and controlled rooms. The venue of the annual symposium 2014 is Naantali Spa in Naantali. The persons involved in the Programme Committee are Satu Salo, Kari Leonsaari, Leila Kakko, Sirkka Malmioja, Antti Mikkola, Raimo Pärssinen and Gun Wirtanen. The editors of the proceedings would like to express their gratitude to the speakers for preparing the abstracts published in the journal Renhetsteknik 1/14 as well as the extended abstracts or full papers published in these electronic proceedings.
This issue of the EFLM EuroLabNews discusses measurement uncertainty in medical laboratories and its importance in ensuring reliable patient results and safety. It summarizes an article on measurement uncertainty that explores the "bottom-up" and "top-down" approaches to estimating uncertainty. The issue also announces upcoming EFLM webinars and conferences, including the 5th EFLM-UEMS European Joint Congress in Laboratory Medicine in Turkey in October 2018 and the 11th International Scientific Meeting on measurement uncertainty in Milan, Italy in November 2017. In addition, it provides updates on EFLM publications and events from national member societies in Italy, Spain, and Kosovo.
The key technological advances in assay development in recent years have been the use of magnetic microspheres and polymer beads as the solid phase in automated immunoassays. This has enabled automation, faster reactions, increased sensitivity, and shorter assay times. Magnetic beads and polymer beads allow assays to work in three dimensions, dramatically increasing surface area and sensitivity compared to traditional ELISAs or coated tubes. IVD manufacturers must consider factors like accuracy, reproducibility, stability, and ease of adaptation when developing assays for instrument systems. Forming collaborations with academic researchers is important for assay development to help discover new biomarkers and opportunities to add new tests.
This document provides information about the "In Vitro Diagnostics: Oncology & Infectious Diseases Conference" being held on November 9-10, 2016 in London. The conference will bring together professionals from hospitals, reference laboratories, and the IVD industry to discuss potential growth in oncology and infectious disease diagnostics and related challenges. Over the two days, the conference will feature keynote presentations, panel discussions, and case studies on topics like emerging regulations, novel cancer markers, rapid testing for infectious diseases, and quality control of point-of-care testing.
The document discusses the International Council for Harmonization (ICH), which aims to harmonize technical requirements for pharmaceutical registration globally. It provides an overview of ICH guidelines, focusing on quality (Q) guidelines for stability testing, impurities, and good manufacturing practices. The Q1A guideline on stability testing recommends long-term storage conditions of 12 months at 25°C/60% RH or 30°C/65% RH for 3 primary batches to evaluate product stability over time under various temperature and humidity conditions.
This document provides information about a clinical quality and compliance masterclass conference taking place on June 16th and 17th, 2016 in Vienna. The conference will focus on managing clinical quality for greater compliance, effectiveness, and audit readiness. Over the two days, there will be keynote speakers from major pharmaceutical companies, case studies, and workshops on topics such as on-site quality improvements, inspection readiness, quality risk management, and third-party oversight. Attendees will include quality assurance professionals from pharmaceutical and biotech companies as well as CROs.
Oral presentation ICC-PBM 2018 @ G-I-N conference Manchester (UK) 2018CEBaP_rkv
The document describes how an international consensus conference on patient blood management (ICC-PBM) integrated the GRADE approach and a formal consensus methodology. A scientific committee formulated 17 questions to guide 3 topics of interest. A 2-day conference included 200 medical experts from 10 disciplines who reviewed evidence using GRADE. It included open sessions for evidence presentation, discussion, and closed executive sessions where decision-making panels drafted recommendations. The process aimed to develop transparent, evidence-based consensus guidelines for optimizing patient blood management.
Hướng dẫn bổ sung về quy trình sản xuất tốt hệ thống hvac cho các hình thức bào chế không tiệt trùng. Xem thêm các tài liệu khác trên kênh của Công ty Cổ phần Tư vấn Thiết kế GMP EU
Purpose of the call:
•Review current data and state of the SSCL
•Discuss the role of communications and team work in patient safety
•Discuss and define how we can measure the effectiveness of the SSCL.
Read more and watch the webinar recording: http://bit.ly/1sXDqaZ
This document discusses assessing the quality of analytical laboratory methods. It provides guidance on method validation and verification, including establishing performance specifications prior to validation. Key steps in validation/verification are outlined, such as defining who should conduct it, what should be evaluated, and when it should take place. The importance of traceability, measurement uncertainty, internal and external quality control data are discussed. The paper aims to help laboratories properly validate methods and ensure high quality testing.
8 CME-Accredited Conferences in Singapore - laboratory Cheryl Prior
From new methods of effective lab management to the development of techniques in detecting diseases, the MEDLAB Asia Pacific conferences will cover an extensive range of topics guaranteed to educate and enlighten all. A wide variety of plenaries and panel discussions focused around laboratory diagnostics will be on offer at the 8 CME-accredited conferences, which are supported by the Academy of Medicine, Singapore. In addition, three new conference tracks are included in the line-up to provide the attendees with even more choice.
This document provides information on two pre-conference workshops at the "Superbugs & Superdrugs" conference on combating antimicrobial resistance.
The first workshop discusses rapid diagnostic tools for infectious diseases, focusing on tracking emerging infections, state-of-the-art diagnostic methods, mobile applications, and challenges in diagnosis.
The second workshop examines how antimicrobial copper touch surfaces can improve patient outcomes and reduce costs by lowering healthcare-associated infections and antimicrobial resistance. It will evaluate the evidence supporting copper's use and discuss cost-benefit analysis and practical implementation.
This document provides information on two pre-conference workshops at the "Superbugs & Superdrugs" conference on combating antimicrobial resistance.
The first workshop discusses rapid diagnostic tools for infectious diseases, focusing on tracking emerging infections, state-of-the-art diagnostic methods, mobile applications, and challenges in diagnosis.
The second workshop examines making materials like copper touch surfaces in healthcare settings to improve patient outcomes and reduce costs by lowering infection rates and antimicrobial resistance. It will evaluate the evidence for copper's antimicrobial efficacy and cost-benefit analysis.
Analytical Science 5th Symposium Programme Registration Form (singlepages)?Graham Sithole?
The document is a program for the 5th Mintek Analytical Science Symposium taking place on October 30th, 2015 at Mintek in South Africa. The morning session will cover topics like celebrating 20 years of ISO17025 accreditation at Mintek and developments in guidance for using reference materials. The afternoon session will discuss root cause analysis, comparing analytical data from multiple laboratories, and applications of technologies like Fourier transform infrared spectroscopy.
2nd European Conference on Clinical ResearchMarket iT
The document provides information on the organizers, program committee, and agenda for the 2nd European Conference on Clinical Research being held from February 2-4, 2015 in Paris, France. The pre-conference on February 2nd will focus on how clinical procurement can provide strategic value beyond cost reductions. The main conference on February 3rd-4th will involve presentations and debates on key issues in clinical research regulation, new technologies, risk management, and the patient's role. Topics will include the impacts and challenges of the new EU Clinical Trials Regulation and new operational practices in clinical trials.
World ADC Frankfurt 2015 - sample brochureWorld ADC
The World ADC Frankfurt meeting has been established with the simple mission of speeding up the development of more potent and safe antibody drug conjugates.
Learn not only how to make an ADC, but how to make a great one. With insights on numerous novel payload technologies, robust strategies for preclinical evaluation and emerging clinical data, there is no better opportunity to accelerate your research.
POINT-of-IMPACT testing. A European perspective - Bert NiestersWAidid
This document discusses point-of-care and point-of-impact molecular diagnostic testing from a European perspective. It describes how molecular diagnostics is moving towards more commercial multiplex assays and automation. Near-patient testing provides results faster but challenges include defining quality indicators for new rapid assays and ensuring clinical relevance. Standards like ISO15189 and ISO22870 provide guidelines for quality control of centralized and decentralized testing. The changing regulatory landscape in Europe aims to improve safety and transparency for in vitro diagnostics.
□ Credit Card
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(4% surcharge for credit card payments)
Card No:
Expiry Date:
Security Code:
Cardholder's Name:
Cardholder's Signature:
Cardholder's Address:
Cancellations: Received in writing (letter or fax) up to 90 days prior to the event will be subject to a
10% administration fee. Refunds are not possible for cancellations received after this date.
Non-payment: If payment is not made at the time of booking, then invoice will be issued. We reserve
the right to charge credit card details provided at time
Pharma IQ brings you Clinical Trial Supply Europe Conference Profit. Successfully cutting costs and overages whilst increasing the flexibility and reactivity of your clinical supply network to support global clinical trials.
R3-Nordic, the Nordic Society of Cleanroom Technology, is a non-profit, independent association for the promotion of new technologies in cleanroom technology and contamination control in the Nordic countries. The aim of the annual R3Nordic Symposium is to provide knowledge within the pharmaceutical, food and electronic industries as well as hospitals and hospital pharmacies. This year the sessions at the 45th R3Nordic Symposium are Pharma, Hospital and General Sessions and the presentations deal with construction and design, planning, auditing, contamination control, cleanroom technology and management, sterilization techniques, cleaning of clean rooms, protective clothing, monitoring techniques, rapid test methods and regulations in clean and controlled rooms. The venue of the annual symposium 2014 is Naantali Spa in Naantali. The persons involved in the Programme Committee are Satu Salo, Kari Leonsaari, Leila Kakko, Sirkka Malmioja, Antti Mikkola, Raimo Pärssinen and Gun Wirtanen. The editors of the proceedings would like to express their gratitude to the speakers for preparing the abstracts published in the journal Renhetsteknik 1/14 as well as the extended abstracts or full papers published in these electronic proceedings.
This issue of the EFLM EuroLabNews discusses measurement uncertainty in medical laboratories and its importance in ensuring reliable patient results and safety. It summarizes an article on measurement uncertainty that explores the "bottom-up" and "top-down" approaches to estimating uncertainty. The issue also announces upcoming EFLM webinars and conferences, including the 5th EFLM-UEMS European Joint Congress in Laboratory Medicine in Turkey in October 2018 and the 11th International Scientific Meeting on measurement uncertainty in Milan, Italy in November 2017. In addition, it provides updates on EFLM publications and events from national member societies in Italy, Spain, and Kosovo.
The key technological advances in assay development in recent years have been the use of magnetic microspheres and polymer beads as the solid phase in automated immunoassays. This has enabled automation, faster reactions, increased sensitivity, and shorter assay times. Magnetic beads and polymer beads allow assays to work in three dimensions, dramatically increasing surface area and sensitivity compared to traditional ELISAs or coated tubes. IVD manufacturers must consider factors like accuracy, reproducibility, stability, and ease of adaptation when developing assays for instrument systems. Forming collaborations with academic researchers is important for assay development to help discover new biomarkers and opportunities to add new tests.
This document provides information about the "In Vitro Diagnostics: Oncology & Infectious Diseases Conference" being held on November 9-10, 2016 in London. The conference will bring together professionals from hospitals, reference laboratories, and the IVD industry to discuss potential growth in oncology and infectious disease diagnostics and related challenges. Over the two days, the conference will feature keynote presentations, panel discussions, and case studies on topics like emerging regulations, novel cancer markers, rapid testing for infectious diseases, and quality control of point-of-care testing.
The document discusses the International Council for Harmonization (ICH), which aims to harmonize technical requirements for pharmaceutical registration globally. It provides an overview of ICH guidelines, focusing on quality (Q) guidelines for stability testing, impurities, and good manufacturing practices. The Q1A guideline on stability testing recommends long-term storage conditions of 12 months at 25°C/60% RH or 30°C/65% RH for 3 primary batches to evaluate product stability over time under various temperature and humidity conditions.
This document provides information about a clinical quality and compliance masterclass conference taking place on June 16th and 17th, 2016 in Vienna. The conference will focus on managing clinical quality for greater compliance, effectiveness, and audit readiness. Over the two days, there will be keynote speakers from major pharmaceutical companies, case studies, and workshops on topics such as on-site quality improvements, inspection readiness, quality risk management, and third-party oversight. Attendees will include quality assurance professionals from pharmaceutical and biotech companies as well as CROs.
Oral presentation ICC-PBM 2018 @ G-I-N conference Manchester (UK) 2018CEBaP_rkv
The document describes how an international consensus conference on patient blood management (ICC-PBM) integrated the GRADE approach and a formal consensus methodology. A scientific committee formulated 17 questions to guide 3 topics of interest. A 2-day conference included 200 medical experts from 10 disciplines who reviewed evidence using GRADE. It included open sessions for evidence presentation, discussion, and closed executive sessions where decision-making panels drafted recommendations. The process aimed to develop transparent, evidence-based consensus guidelines for optimizing patient blood management.
Hướng dẫn bổ sung về quy trình sản xuất tốt hệ thống hvac cho các hình thức bào chế không tiệt trùng. Xem thêm các tài liệu khác trên kênh của Công ty Cổ phần Tư vấn Thiết kế GMP EU
Purpose of the call:
•Review current data and state of the SSCL
•Discuss the role of communications and team work in patient safety
•Discuss and define how we can measure the effectiveness of the SSCL.
Read more and watch the webinar recording: http://bit.ly/1sXDqaZ
This document discusses assessing the quality of analytical laboratory methods. It provides guidance on method validation and verification, including establishing performance specifications prior to validation. Key steps in validation/verification are outlined, such as defining who should conduct it, what should be evaluated, and when it should take place. The importance of traceability, measurement uncertainty, internal and external quality control data are discussed. The paper aims to help laboratories properly validate methods and ensure high quality testing.
8 CME-Accredited Conferences in Singapore - laboratory Cheryl Prior
From new methods of effective lab management to the development of techniques in detecting diseases, the MEDLAB Asia Pacific conferences will cover an extensive range of topics guaranteed to educate and enlighten all. A wide variety of plenaries and panel discussions focused around laboratory diagnostics will be on offer at the 8 CME-accredited conferences, which are supported by the Academy of Medicine, Singapore. In addition, three new conference tracks are included in the line-up to provide the attendees with even more choice.
This document provides information on two pre-conference workshops at the "Superbugs & Superdrugs" conference on combating antimicrobial resistance.
The first workshop discusses rapid diagnostic tools for infectious diseases, focusing on tracking emerging infections, state-of-the-art diagnostic methods, mobile applications, and challenges in diagnosis.
The second workshop examines how antimicrobial copper touch surfaces can improve patient outcomes and reduce costs by lowering healthcare-associated infections and antimicrobial resistance. It will evaluate the evidence supporting copper's use and discuss cost-benefit analysis and practical implementation.
This document provides information on two pre-conference workshops at the "Superbugs & Superdrugs" conference on combating antimicrobial resistance.
The first workshop discusses rapid diagnostic tools for infectious diseases, focusing on tracking emerging infections, state-of-the-art diagnostic methods, mobile applications, and challenges in diagnosis.
The second workshop examines making materials like copper touch surfaces in healthcare settings to improve patient outcomes and reduce costs by lowering infection rates and antimicrobial resistance. It will evaluate the evidence for copper's antimicrobial efficacy and cost-benefit analysis.
1. Quality in the Spotlight
Conference
Elzenveld in Antwerp, Belgium 2016, 14th
and 15th
March
Secretary Mrs. Lia Konings and Chair Dr. Henk Goldschmidt, Foundation DCT, PO box 4201, 5004 JE Tilburg, The Netherlands.
Tel. +31 85 401 8766 , Fax. +31 85 401 8764, E-mail: TQMantwerp@gmail.com, Website: www.qualityspotlight.com
2. The Antwerp conference‘quality in the spotlight’is a two-day conference on quality in medical laboratories.
Over the years various quality related issues were addressed in a scientific setting where we learned from
each other and from internationally well- known speakers. As a result, a rather boring subject was made
pretty interesting!
While we placed quality in the spotlight, often laboratory medicine was actually in the spotlight because
we took advantage of Jim Westgard’s longitudinal rules (the Westgard rules) within and between laboratory
controls. This needs more work!!
3. In addition concepts such as biological variation, quality regulations and medical allowable errors were
highlighted. We also tried to have these different aspects work together.
The coming conference is no different. We will continue to push the envelope! So join in, contribute and
enjoy. We, together, have more work to do!
4. The Milan (IT) conference:“1st EFLM Strategic Conference‘Defining analytical performance goals - 15 years
after the Stockholm Conference’’’created some confusion. So, it is now time for the clean-up!
Cleaning up the mess: James Westgard (right) and Henk Goldschmidt at work!
To“clear the mess”, different aspects of quality have to be combined in such a way so that the various parts
work together. This means that the processes of manufacturing instruments and reagents, obtaining the
sample, conducting the measurement, reporting, and interpreting the result for use in a clinical setting
should all work together. This defines the loop. It also defines the quality‘fit for use.’
5. sday
Quality performance specifications
Cleaning up our thoughts
Over a year ago (November 24th and 25th, 2014) the European Federation of Clinical Chemistry and
Laboratory Medicine organized the first strategic conference in Milan (IT) to consider and discuss, from
various perspectives, performance specifications of medical laboratory tests. The conference readdressed
the“Consensus Agreement”from Stockholm. The papers from Milan’s conference are published in Clin
Chem Lab Med 2015; 53: 829-958.
However, some of the outcomes from this meeting have generated discussion in the scientific community.
It has been argued that comments on the Stockholm conference made in Antwerp in 2004 (Accred Qual
Assur 2004, 9:125 - 127), and the NEXUS concept outlined also in Antwerp in 2005 (Clin Chem Lab Med
2004, 42:868 - 873) have not been taken into account.
At this Antwerp meeting, we will continue to discuss the Stockholm and Milan outcomes using an open,
independent, and out - of – the – box approach. As in the past we will publish a new set of consensus
statements.
The layout of the second day of this conference is designed to reach an understanding of the meaning of
quality characteristics in laboratory medicine. From the TE concept generating a total allowable laboratory
error per test, we found a way to incorporate the concept of biological variation and create a NEXUS
concept. So what will be next?
As with previous meetings, new ideas and questions will be posted. But, these need to be tested and
evaluated. All this requires science and scientific debate. Join us in Antwerp for that debate.
09.00 – 09.05 Welcome and opening
Sunday March 13th 2016
17.00 - 18.00 Registration desk open - welcome drink for all participants at the
conference centre
20.00 Speakers dinner in town
6. Day 1 Monday March 14th 2016
09.00 – 09.05 Welcome and opening conference
Pushing the envelope
09.05 - 10.15 Overview
09.05 – 09.40 Callum Fraser
Stockholm consensus document and the Antwerp and EQALM comments on this) as a
background for the 1th EFLM Strategic conference.
09.40 – 10.15 Sverre Sandberg
statement and how are the results from the Strategic conference taken forward. Is it
10. 15 – 10.45
7. 10.45 - 11.20 Rainer Haeckel
Common concepts for establishing permissible uncertainty limits is to relate them on
biological variation defining the rate of false positive results (model 1) or to base the
limits on the state-of-the-art (model 2). The approach on biological variation should
be preferred. Hitherto, recommendations were based on a linear relationship between
biological and analytical variation leading to limits which are too stringent or too
permissive. A working group of the DGKL proposes a combination of both models
to overcome some disadvantages. The proposal is based on a non-linear relationship
between biological and analytical variation leading to more realistic limits. The proposed
algorithms can be applied to all measurands and considers any quantity to be assured.
11.20 - 11.40 Sten Westgard
“Practical value of TAE in laboratory quality management”
Historical review of quality control, quality assessment and quality management from Dr.
Eugene K. Harris at the Aspen conference in 1976, through the Westgard rules into biology
and beyond.
11.40 - 12.00 Elvar Theodorsson
Total error versus measurement uncertainty: revolution or evolution?
The error paradigm including total error and allowable total error struggles when repre-
senting numerous and complex factors influencing measurement results and commonly
resorts to the simplest models of reality. The uncertainty paradigm suffers from complex
mathematics and conceived impracticability in clinical chemistry.
The pros and cons of the total error and uncertainty paradigms need to be debated, ma-
king way for methods that can incorporate all relevant causes of uncertainty when making
medical diagnoses and monitoring treatment effects. This development should preferably
proceed as an evolution and not as a revolution.
12.00 – 12.35 Mauro Panteghini
Allowable limits for measurement uncertainty across the traceability chain. Who is
responsible for uncertainty at the different levels, industry, laboratories, users etc. ?
An overview from the IFCC working group, The Milan Conference and the Paris meeting.
12.35 - 14.00 Lunch break
8. 14.00 – 14.30 David Armbruster
Measurement Uncertainty (MU, m): Significance for the IVD Industry
After enactment of the In Vitro Diagnostics Directive (IVDD) in 2003, manufacturers have
been adapting the principles of Metrology and in particular the concept of traceability.
A formal traceability chain includes estimates of measurement uncertainty at every step.
Identifying the sources of variability in the manufacturing process and quantitating them
by estimating uncertainty allows manufacturers to minimize lot-to-lot variability for cali-
brators, controls, and reagents. However there are various options for calculating uncer-
tainty and there is not yet an internationally accepted standard approach. Uncertainty is a
useful concept for Industry because it allows manufacturers to better control and monitor
the production of assay components. The manufacturer’s responsibility ends with provi-
ding the uncertainty along with the target value of its products. Considerably more varia-
bility (uncertainty) is introduced when a manufacturer’s assays are used in the“real world”
of the clinical laboratory. The IVD Industry is challenged both with understanding how to
account for uncertainty in the manufacturing process and how to explain uncertainty and
its meaning to customers.
14.30 – 15.00 Jim Westgard
Resolving the battle between Total Analytic Error (TAE) and Measurement Uncertainty
(MU). Comments and recommendations for establishing a comprehensive Quality Ma-
nagement System where accuracy is measured by TAE in the medical laboratory, tracea-
bility is measured by MU by manufacturers, and comparability is monitored by the Sigma
quality achieved in PT/EQA programs.
15.00 – 15.30 Jan Krouwer
“TAE vs MU: What to do?”
Straightforward, out – of – the - box comments about the“total”in total error in medical
laboratories from an industrial background including risk assessment strategies. Including
comments on the paper“Proposal fot the modification of the conventional model for
establishing performance specifications”(CCLM 2015: 53 (6) 925 – 937). Total error,
Stockholm and Antwerp statements, are also discussed.
15.30 - 15.45 Tea break
9. 15.45 – 15.55 Discussion and preliminary design of a set of consensus statements. Part 1.
Is it possible to blend a hardcore industrial approach (ISO 9001, GUM) with biological
and other (e.g., medical decision) quality characteristics into one model (ISO 15189). The
lecture of David Burnett at the Antwerp meeting in 2007 was very helpful in that respect.
But now we need a strict definition and proper formulas. An update and clearness is
needed after Stockholm 1999, Antwerp 2004 and Milan 2014.
15.55 – 16.00 Westgard award ceremony
16.00 – 16.35 Prof. Linda Thienpont
This is the Westgard awardee lecture. It will deal with how traditional quality control in
medical laboratories potentially can be improved. Two new tools for direct monitoring of
patient medians and flagging rates will be presented. The first allows to assess the stability
of laboratory/instrument performance on patient samples in comparison to the peer and
the second translates the effect of instability on the flagging rate. Besides contributing
to understanding of laboratory and test differences, the tools may also be able to
demonstrate the validity of bias correction factors commonly used by individual
laboratories or introduced on a national scale.
16.35 - 16.45 Closing
17.00 - 17.45 Reception at the Antwerp townhall
18.30 -22.30 Dinner at the conference venue
Admission to the dinner only by dinner ticket.
Dinner speech by Joris Delanghe
“Antwerp: town on the crossroads of Europe or where
cultures clashed in the past.”
10. Day 2 Tuesday March 15th 2016
09.00 – 09.05 Opening conference: back to reality
POCT
POCT really is taking off. In many physicians’offices, analytical instruments appear and the gamut of
available tests enlarges. Not only are CRP, glucose and pregnancy tested for, but also HbA1c, HDL-
cholesterol, BNP and HIV. Is the quality well defined; who is responsible for a correct analytical test result,
the interpretation and archiving?
Technology is changing our world and also our perception and assessment of quality. For instance in the
larger American institutions (e.g., St Louis Medical System), the control of the number and quality delivered
by POCT glucose meters used throughout the hospital is totally lost. Yet, correct results for the 12% of
critically ill patients is essential.
09.05 – 09.35 Viviane van Hoof
POCT, practical implications within and outside the hospital: guidelines from the Dutch
and the Belgian working groups. (How)Can the quality of POCT results be guaranteed?
Who is responsible? Does POCT work without medical lab involvement? POCT testing
means convenience, but this is not always the best choice. Never underestimate the
emotional impact of POCT on the physician, the physician’s assistant as well as on the
patient. Is there a definition for“proper lab test data”? What are we selling now and in the
(near) future with POCT?
09.35 – 10.05 Sharon Ehrmeyer
POCT quality systems, such as CLIA and ISO 15189, have very different QC and QA
guidelines. The U.S. bases the CLIA guidelines on test complexity.
- How would you rate a test as simple or as complex, waived or nonwaived?
- Which risks are involved when wrongly performed?
- Who is responsible, who can be prosecuted?
10.05 - 10.35 Coffie break
11. Network laboratories
Network laboratories, with a high degree of specialization, become joint ventures between existing
laboratories. Personalized medicine and DNA testing require specialization and enormous investment
in equipment as well as personnel, making joint ventures within existing laboratory networks the only
solution. While this is the technological forefront in our field, who is responsible and how is quality
guaranteed?
10.35 – 11.05 Marc Van Den Bulcke
The Belgium Cancer Centre hosted by the Scientific Institute of Public Health coordinates
the implementation of‘Next-Generation Sequencing’(NGS) testing into routine practice at
the hospitals. NGS routine application will at first focus on tumor marker testing for clinical
utility. This implementation will be organized through a pilot study wherein a number of
new challenges for the laboratories will be addressed: cost-effective management through
network organization, accreditation and external quality assessment for molecular
NGS tests in (hemato) oncology, informed consent and privacy guarantee on genomic
test data, training and education of personnel, data management and registration,
reimbursement procedure. Each of these topics will be addressed and a status on the
implementation will be presented.
11.05 – 11.35 Joris Delanghe
How much confidence should the requesting physician have in the laboratory system?
Does it make sense to ask for quality control data next to the reported test results?
12. Quality systems
Quality systems such as CLIA, ISO15189 and ISQua do not compensate for the lack of quality and
competence of the individual health care worker (regardless of where located). On various levels in a
health care organization, a lot of“rubbish”is communicated from employees (e.g., nurses) to customers
(e.g., patients) and very often just to please the patient. From the employee’s point of view, the“very often”
occurrence is not meant to be malicious. However, the consequences can be devastating for the patient.
In addition to potential poor healthcare outcomes, a long lasting feeling of dissatisfaction often follows
the interaction. How can we return to a traditional, individualized sense of quality that provides patient
satisfaction?
11.35 – 12.05 Stacy Walz
Quality obtained in US laboratories is primarily defined by CLIA, while the FDA guards the
quality of laboratory reagents. But who defines the quality of laboratory personnel, their
performance, and the impact on the final quality of the test results?
12.05 – 12.35 Christine Van Laer and Astrid Coppens
Quality in Belgium laboratories. These laboratories are cost effective,
friendly, customer directed and provide adequate consultation on various
levels for colleagues, requesting physicians as well as patients. Being a part
of the lab, are you willing to communicate with patients? And what are
you willing to say; what kind of information will you provide, using which
tools?
12.35 - 14.00 Lunch break
13. New technologies
14.00 – 14.30 Henk Goldschmidt
Report from AACC 2015. Elizabeth Holmes created a paradigm shift in laboratory testing
that is patient centered, cheaper, and delivers results faster. Is this really true? Like other
innovations and promises, there are believers and non-believers. Chips are implemented
to measure and influence certain body functionalities; the Nautilos project measures
certain defined spots within the body. While continuous monitoring makes it possible to
understand much more of the physical status of the patient, should these new approaches
be cost-focused or just information focused on health and wellness?
14.30 – 15.15 Industrial snapshots
15.15 - 15.45 Tea break
Practical Quality Management
15.45 – 16.15 Marc Thelen
The SKML is the Dutch organiser of external quality assessment schemes for all disciplines
in laboratory medicine. The SKML feels a responsibility to do more than just compare
laboratories. In case of differences between laboratories, SKML thinks that not the
consensus or majority, but the truth should set the goal. Therefore SKML takes lead in
the process of standardisation and harmonisation of laboratory results. The SKML is
internationally well known and appreciated for its class A scheme for general clinical
chemistry based on 24 commutable samples per year with value assignment in reference
laboratories employing reference methods. By providing such a robust anchor for trueness
verification to its participants, SKML reports are used by participants to correct for
imperfections of the metrological traceability according to ISO17511 by IVD providers.
16.15 – 16.30 Discussion and preliminary design of a set of consensus statements. Part 2.
Is it possible to blend a hardcore industrial approach (ISO 9001, GUM) with biological
and other (e.g., medical decision) quality characteristics into one model (ISO 15189). The
lecture of David Burnett at the Antwerp meeting in 2007 was very helpful in that respect.
But now we need a strict definition and proper formulas. An update and clearness is
needed after Stockholm 1999, Antwerp 2004 and Milan 2014.
14. 16.50 - 17.00 Closing remarks
17.00 - 17.30 Social gathering
Antwerp 2016
Conference venue: ‘t Elzenveld situated at the Lange Gasthuisstraat 45 in Antwerp, Belgium.
The Elzenveld, dated XIIth century, was the first“hospitale infirmorum”in Antwerp. The oldest still intact
building is the nave of the chapel, erected around 1397 and extended with a spacious choir between
1443-1460. The Elzenveld is a socio-cultural center nowadays. The lectures are held in the Dr. L. Marquis
auditorium. The poster session and industrial exhibitions will take place in the Kanunnik van Gessel hall.
15. Abstract Submission Form for Posters
Fill in the form and save it as MS word document under“Name.poster.doc”
Send it to: TQMantwerp@gmail.com and vivienne@prikdienstnederland.nl confirming the
reception will be sent to the e-mail address indicated in the form
E-mail address:
Title of the poster:
Name and Title of the Corresponding and presenting author
Additional Authors
Abstract: Maximum 200 words; use font Times New Roman 12
16. Posters will be on display during the entire conference, with appointed times for interaction with the
authors.
Posters will cover a wide range of subjects including: software for QM, accreditation costs, laboratory-hos-
pital interface, reference materials, error management, validation, and human resources management. A
poster award will be presented at the Conference Dinner.
Submissions for the poster session will be reviewed by the program committee on the basis of a short ab-
stract of not more than 200 words. As a guideline, the following questions should be answered:
• Describe the problem you have addressed.
• Why is this problem important?
• What is the original contribution of this work?
• Does it check and/or extend previously reported work?
Optional: if accepted, the author may choose to prepare a full paper on the topic for publication in the
workshop proceedings.
Proceedings
Proceedings were published in the“Journal of Accreditation and
Quality Assurance”, at least in part. The papers in JAQA give a fair impression
of what the quality communion kept busy over the last decade. So far so good.
What will happen with the papers during the next decade is unclear.
The conference organization is still looking for a proper platform to publish.
17. Practical information
Conference Location
Antwerp lies at the heart of the European Union: It is a lively city whose international feeling and hospita-
ble people enthusiastically welcome foreign guests.
The town first became a world commercial centre in the sixteenth century and was
the cradle of commercial printing and Flemish art. It possesses a very large and
vigorous harbor as well as being the diamond centre of the world.
The city is a mixture of many cultures. The citizens are called Sinjoors (Seigneurs)
because of their elegance and enthusiasm for style and Burgundian way of life.
This international awareness makes each person a citizen of the world and keenly
supportive of commerce, industry, art and culture. The blinding success of Antwerp,
designated the“cultural”capital of Europe in1993, illuminated this yet again.
Antwerp, in the heart of Europe and Benelux and less than an hour away from the Community headquar-
ters, is a city which is fully alive day and night. On the Schelde river, this metropolis welcomes merchants,
businessmen, artists and travelers from all over the world. Spaniards, Jews, Greeks, Turks, Russians, Dutch-
men, Germans, Chinese, Indians and Americans, to name but a few, are represented among the more than
135 nationalities which are at home in this world-class city. The various nationalities have their own clubs,
centres, and religious institutions, which go towards making Antwerp into a cosmopolitan region.
Conference address: Conference Center“’t Elzenveld”
Lange Gasthuisstraat 33-45
B-2000 Antwerp
Tel. +32-3-2027771
Fax. +32-3-2027775
Address for Conference information
Dr. H.M.J. Goldschmidt, Foundation DCT, P.O. box 4201, 5004 JE Tilburg,
The Netherlands. Tel: +31 854018766, Fax: +31 854018764, E-mail: TQMantwerp@gmail.com
Website: www.QualitySpotlight.com
Secretary of the conference Mrs. Lia Konings , Tel: 0492-529416 E-mail: TQMantwerp@gmail.com
18. Registration desk
The registration desk and conference secretariat are located in the Main Hall of the Congress Center.
The secretariat will be open:
Sunday March 13th, from 16.00 till 20.00
Monday March 14th, from 08.30 till 18.00
Tuesday March 15th, from 08.30 till 18.00
Venues
The Scientific program, symposium lunch and coffee breaks, poster exhibition and commercial exhibition
will all take place in the Congress Center,‘t Elzenveld’
Registration fees
Please use the attached registration form and return it as soon as possible to Dr. H.M.J. Goldschmidt or Vivi-
enne van Benthem or Lia Konings, together with the full registration fee(s).
Your registration will then be confirmed. For payment instructions, please see below.
Registration Before January 1st 2016: € 705
After January 1st 2016: € 755
These fee cover:
• participation in all scientific sessions
• symposium program
• abstract book
• lunches
• morning and afternoon refreshments
• welcome and farwell receptions at the Elzenveld
Payment instructions
Participants are kindly requested to forward their registration fees, in Euro’s, by bank transfer to the follo-
wing bank account:
ABN-AMRO Bank, Heuvelring 88, 5038 CL Tilburg, The Netherlands
Account No: 63.08.57.385 IBA N: NL56ABNA 0630 8573 85 BIC code: ABNANL2A
Account holder: Foundation The Quality Meetings, Tilbutg, The Netherlands
Please indicate the names of the participants on all payment documents;
or if known, the registration number.
19. Registration and receipt of fees will be acknowledged upon receiving payment. Please note that no
registration will be finalized without proof of prepayment.
Use of credit card
Payment can only be made by Visa credit card
Cancellation of registration
Registration fees less 50 euro for administrative costs, if written notice of cancellation is received before
February 1st, 2016
No refunds will be made after this date.
Proceedings
Extra copies of the proceedings can be ordered during the conference for € 75,-. This fee includes postage
and handling.
Accommodation
The following hotels have been suggested as the conference hotels:
Theater Hotel ****
Location: Arenbergstraat 30 (5 min*)
Hotel Ibis Antwerpen Centrum ***
Location: Meistraat 39 (5 min*)
* walking distance to the Congress Center
In previous years we arranged a booking agency. But nowadays it is so easy to take care of this through
the internet using various booking site, we would like to suggest to do so. Trivago.com, Booking.com and
others facilitate such as well as the possibility to compare hotels and, in that way, fine-tune your booking.
If you need assistance, please contact Lia Konings or Vivienne van Benthem via TQMantwerp@gmail.com
or Vivienne@prikdienstnederland.nl and we are pleased to help you out.
20. Access to Antwerp
A. From Brussels airport (by train)
There are train connections every 20 minutes from Brussels Airport to the Brussels North Station.
The journey to Antwerp Railway Station from Brussels North Station takes about 50 minutes.
Antwerp Railway Station is a 15-minute walk from the conference site. A taxi takes about 10 minutes.
There are city buses, but no subway in Antwerp.
B. By car
Antwerp is easy to reach by car, following the E19 motorway from Brussels.
Car rental. Most major car rental companies have a desk at the Brussels Airport.
Parking facilities are available nearby the conference venue. Please note that you have to pay for your par-
king place.
C. By train from Brussels North Station
There are several trains per hour from Brussels North Station to Antwerp. The fare for a single journey is
approximately 8 Euro and the journey takes about 50 minutes.
Bank and Post office
Banks are open from 9.00 - 16.00 hrs.
The main post office is open until 18.00 hrs.
Emergencies in Belgium
The number for emergency calls is 112.
Insurance disclaimer
While the Organizing Committee and Conference Secretariat have made every effort to ensure the safety
and well-being of all conference members and their associates, responsibility cannot be taken for any ac-
cidents or damage that may occur during the symposium.
Speakers briefing
Speakers should meet their session chairmen in the room of the presentation 20 minutes before the start
of the session.
21. Social program
On Sunday evening (17.00 – 18.00 hour) a Welcome Cocktail will be
provided by the conference organization. The Conference Dinner is
planned in the“ kloosterzalen”of the Elzenveldcentre at Monday,
March 14th.
The cost for the Conference Dinner is € 95 per person.
Students
Limited funding for travel and attendance of the meeting may become
available. Students (no others!) in need of financial assistance are requested
to apply in writing through the Secretariat to the Chairman of the
Organising Committee before January 1st, 2016. A copy of the studentcard
should be enclosed.
General Information
The meeting will be held in the Elzenveld in Antwerp (Belgium). The program consists of plenary sessions
and poster presentations. The working language will be English, no simultaneous translation facilities will
be provided.
Acknowledgements
This symposium has been made possible, in part, by the financial support of the following companies
sponsoring: Alere, DCT, pending.
22. How technology influences the quality management in laboratory medicine
So we have some Gordian Knots to solve…
website: http://www.QualitySpotlight.com
Conference address:
Conference Center‘t Elzenveld
Lange Gasthuisstraat 45,
B-2000 Antwerp, Belgium.
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