Organized by:		Supported by:

Registration fees for foreign participants are as follows:

* Associate participants are Members, Affiliates and Fellows of IUPAC, CITAC and Eurachem

Registration fees for Israeli participants are as follows (Not including VAT):

Invitation Letter

On behalf of the International Advisory Committee it is my pleasure to invite you to participate in the International Workshop on Validation of Test Methods, Human Errors and Measurement Uncertainty of Results, 23 Jan 2017, Sheraton Tel-Aviv Hotel, in conjunction with Isranalytica Conference and Exhibition, 24-25 Jan 2017, Tel Aviv, Israel, as its satellite event.  

Validation of test (chemical analytical) methods is one of basic requirements for the competence of testing and calibration laboratories (ISO 17025), and reference measurement laboratories in laboratory medicine (ISO 15195). The same is required by national regulators, such as U.S. Food and Drug Administration, UK Medicines and Healthcare products Regulatory Agency, and others. There are a number of guidelines of different industries and chemical analytical societies, adapted these requirements for specific purposes and laboratories.

Human Error Study as a Part of Method Validation Task

Ilya Kuselman has received his Ph.D. diploma in inorganic chemistry from Kalinin State University, Russia, in 1974, and D.Sc. in analytical chemistry – from R&D Institute for Rare Metal Industry, Moscow, Russia, in 1989. From 1991 to 2014 he was a co-worker and further Director of the National Physical Laboratory of Israel. Currently Ilya is an Independent Consultant on Metrology. He has published above 200 papers in reputed journals in the fields of metrology and quality in analytical chemistry.

Evaluation of Probabilities of False Decisions at Conformity Assessment of Test Results

Dr. Francesca Romana Pennecchi holds a European PhD in “Metrology: measurement science and technique”, from the Politecnico of Torino (PoliTo), Italy. She is a permanent researcher at the Istituto Nazionale di Ricerca Metrologica (INRIM, Italy), within the Division “Quality of Life”. She was granted a research collaboration at the National Physical Laboratory (NPL), UK, in 2003, and a research grant at the Statistical Engineering Division of the National Institute of Standards and Technology (NIST), USA, in 2007.

Handling Different Matrices in Validation of Analytical Methods Based on LC/MS

Anneli Kruve obtained her PhD from University of Tartu (UT) in 2011. Since 2005 she has been involved in HPLC and LC/MS method development and validation in various fields: bioanalysis, food analysis as well as industrial analysis. Starting from 2011 she works as a research fellow at UT Institute of Chemistry. In 2008 and 2009 she has worked in University of Helsinki in the field on miniaturization of MS ion sources.

Setting and Using Target Uncertainty in Chemical Measurement

Prof. Ricardo J. N. Bettencourt da Silva is a Researcher of the Centro de Química Estrutural of the University of Lisbon and has been teaching analytical chemistry and metrology in chemistry at the Faculty of Sciences of the University of Lisbon. The main topics of his research are metrology and examinology in chemistry, the sciences of quantitative and qualitative evaluations in chemistry respectively. For both kinds of evaluations, detailed measurement and examination models are developed so as to extract reliable and more information from complex systems.

Validation of qualitative methods: Evaluation of repeatability and reproducibility

Emil Bashkansky, D.Sc., Professor of the Department of Industrial Engineering & Management at ORT Braude College. The focus of his research activity is measurement theory. He is the author of about 80 peer-reviewed papers, published in international scientific journals and conference proceedings. He is a co-author of the ISO/REMCO/TR79 "Reference Materials-Examples of Reference Materials for Qualitative Properties", and has been involved in a number of other international projects and conference program committees.

Dr. Bertil Magnusson

The Fitness for Purpose of Analytical Methods: a Laboratory Method Validation and Related Topics

Started as a marine chemist looking for traces of metals in the Oceans, rivers, lakes and rain in the 70's. At that time clean room and clean sampling was something totally new in the chemical laboratory. After PhD in 1981 he joined a chemical company, Eka Chemicals within AKZO-NOBEL and worked there as a specialist in analytical chemistry mainly with spectroscopy (XRF; XRD, ICP) and wet chemistry. The work included support for all laboratories within the company in Europe and America.

AQbD in practice: Risk assessment based on FMEA methodology is applied for complex sample preparations and chromatographic impurities separation

Dr. Bianca Avramovitch is Senior Director in the R&D of Teva Pharmaceuticals, filling a number of positions: Global Analytical R&D  Forum Leader, Head of Analytical Technologies Unit (ATU) of the Generic R&D IL, Global AQbD Leader and Global ELN (Electronic Notebooks) Platform Business Owner.

Method Validation, Can the Theory Work in Reality? - Pharmaceutical Industry Experience

Dr. Orna Dreazen holds a Ph.D in Biochemistry from the Weizmann Institute of Science. Her postdoctoral studies were completed at University of California in Los Angeles. In 1994 she received a diploma in Business Administration from the Tel Aviv University.

Analytical Test Methods – to Err is Human.
Practical Application of Risk Management to Analytical Testing

Peak purity and spectral matching during validation of LC methods

Dr. Shulamit Levin has more than 36 years of experience in analytical chemistry, especially LC (HPLC and U-HPLC) and LC-MS.  She is the scientific consultant of Waters Israel, and acts as Waters’ Chemistry, Instrumentation and Software specialist in Israel. 

ISO/IEC 17025:2017 the new upcoming version

Since 2006 Ilan Landsman serving at ISRAC-Israel Laboratory Accreditation Authority, current position as Accreditation Deputy General Manager.
1986 to 2006 Established and worked at calibration laboratory accredited to ISO/IEC 17025 since 1996 as technical manager for 20 years and quality assurance manager 3 years, CEO for 5 years (time period overlaps).

Round-table discussion: How can be validation planned to provide a method user with maximum information?

BR Consulting

Raphael Bar (Ph.D. in Chemistry 1984) is presently a pharmaceutical consultant for the Pharma and bio-Pharma industries. He is consulting various companies and provides development and analytical support to investigational, generic, new drugs as well as combination device-drug products.  After a postdoc in biochemical engineering at UVA (Va, USA), he joined the Hebrew University as a Lecturer in the Biotechnology program. He then joined the pharmaceutical industry to manage analytical R&D and QC laboratories. 

Round-table discussion: Are there relationships between method validation, human errors and estimation of measurement uncertainty?

Istituto Nazionale di Ricerca Metrologica (INRIM), Italy
m.sega@inrim.it

Dr. Michela Sega is a chemists and holds a PhD in “Chemical Sciences”, from the University of Torino, Italy. She is a permanent researcher at the Italian Metrology Institute “Istituto Nazionale di Ricerca Metrologica – INRIM” within the Quality of Life Division. She leads the laboratory of “Primary gravimetric gas mixtures and organic analysis”.