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Accredited by BMWFW – member of EA and ILAC

Training Programme

Laboratory Quality Manager and Laboratory Assessor

17 – 28 November 2014

Vienna, Austria


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IMPORTANT INFORMATION OVERVIEW The European Organization for Quality training course is designed to teach laboratory personnel and future laboratory assessors how to install, maintain and improve Laboratory Quality Management System that meets the requirements of ISO/IEC 17025, ISO 15189:2012 Standards and OECD GLP, and applicable for the laboratories of any size and any activities related to calibration and testing. In addition, this course gives essential knowledge required for Laboratory Quality Manager to act as the management representative and as the promoter of the customer requirements awareness throughout the organization and for Laboratory Assessors to apply management skills required in the execution of an audit. After this training the participants will be able to perform internal and third party audits proving conformance with the relevant standards and technical recommendations (e.g. ISO 17025:2005, ISO 15189:2012 and OECD GLP) taking laboratory orientation into account where necessary. This modular training program includes 9 interrelated workshop and examination: Workshop 01: Understanding ISO/IEC 17025:2005 and ISO 15189:2012 Management System

Workshop 02: Quality Assurance and Quality Documentation in Calibration and Testing Laboratories

Workshop 03: Basic Statistical Tools for Laboratories

Workshop 04: Internal Quality Control for Laboratories

Workshop 05: Quantifying Uncertainty in Analytical Measurements

Workshop 06: Traceability in Chemical Measurements

Workshop 07: Inter-laboratory Quality Control Measures

Workshop 08: Project Management: Implementing Quality Management System in Laboratories

Workshop 09: Laboratory Audit

The workshops also can be attended selectively, and the participants will be awarded a certificate of completion. Target Audience – Laboratory managers, quality assurance officers, and laboratory staff dealing with quality of analysis and/or calibration in food, environmental, electronic, chemical, and pharmaceutical laboratories; laboratory assessors. Minimum requirements to participants – It is recommended that participants of the training course have either university degree or equivalent in chemistry, physics, engineering or relevant field or secondary education plus two years experience in testing or calibration laboratory. Working language of the training course - English


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CERTIFICATES Upon successful completion of the examination the participants are entitled to apply for European Organization for Quality (EOQ) certificates of Laboratory Quality Managers and Assessors. The certificate is valid in 34 countries. EOQ certificate is subject to EOQ rules and regulations.


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DAY 1 17 NOVEMBER 2014

Opening Session

9.00-10.30 am Registration. Welcome speech. Objectives and Scope of the Program.

Introduction of Participants.

Workshop 01: Understanding of Laboratory Quality Management System

Introduction to ISO/IEC 17025 and the Implication for the Laboratories

Interrelation with ISO 9001:2008, ISO 15189:2012 and GLP Standards

History of Quality Requirements of Chemical Analytical Measurements

Modern quality requirement, international regulations related to quality of analytical measurements, international accreditation network

10.30–10.45 am Coffee break

10.45-12.30 am General Quality Management System Requirements to Testing Laboratories

Managerial and Functional Elements of a Calibration and Testing Laboratory

Management Responsibility

12.30–1.30 pm Lunch

1.30-2.45 pm Technical requirements of ISO 17025:2005 and ISO 15189:2012 Standards

2.45–3.00 pm Coffee break

3.00-5.00 pm Group work 1


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Workshop 02: Quality Assurance and Quality Documentation in Calibration and Testing Laboratories

9.00-10.30 am Basic elements and principles

Tools and terminology

Documentation and traceability

Documented procedures and processes and IT-tools

Documented responsibilities

Forms, files, plans and records

Documented material, personnel and external partners


10.45-12.30 am The way from SOPs to the Quality Manual

Quality records: Nonconformities, complaints and mistakes

Management review and documented continuous improvement

12.30–1.30 pm Lunch

1.30-2.45 pm Document Management System

Establishing, authorizing, spreading, changing, archiving documents

Document security and responsibility

Software support and solutions for Q-documentation


3.00-5.00 pm Group work 2: practical exercises


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Workshop 03: Basic Statistical Tools for Laboratories

9.00-10.30 am Errors in Quantitative Testing, Gross, Random and Systematic Errors.

Accuracy and Precision; Repeatability and Reproducibility.

Handling Systematic Errors in Testing and Calibration Laboratories.


10.45-12.30 am Characteristics of Data Population, Mean and Standard Deviation.

The Normal or Gaussian Distribution, Other Types of Distribution.

Tolerance and Confidence Intervals.

Propagation of Errors.

12.30–1.30 pm Lunch

Workshop 04: Internal Quality Control for Laboratories: Significance Tests

1.30-2.45 pm Significance Tests.

Pared T-test.

F-test for Comparison of Standard Deviations.

Outliers Test. Testing for normality.




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Workshop 04: Internal Quality Control for Laboratories: Analysis of Variance (ANOVA)

9.00-10.30 am Analysis of Variance (ANOVA)

Separation and Estimation of Variances by Using ANOVA

Analyzing Significance of Results

The Uses of ANOVA

10.30–10.45 am Coffee break 10.45-12.30 am Group work 4: practical examples 12.30–1.30 pm Lunch Workshop 05: Quantifying Uncertainty in Analytical Measurements

1.30-2.45 pm Definition of Uncertainty

Uncertainty Sources and Components

The Process of Uncertainty Estimation

Methods for Estimation Uncertainty

„Top-down“ and „Bottom-up“ Approaches: Advantages and Drawbacks Standard Uncertainties and Combined Standard Uncertainty

Expanded Uncertainty

Reporting Uncertainty


3.00-5.00 pm Group work 5: practical exercises


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DAY 5 21 NOVEMBER 2014 .

9.00-10.30 am Definition and Explanation of Traceability

Traceability of the Results and QA system

International System of Quantities and Units (SI)

Treceability of Measuring Standards

Certified Reference Materials (CRM) and Reference Materials (RM): Terminology, Types, Production and Uses

10.30–10.45 am Coffee break Workshop 06: Traceability in Chemical Measurements

10.45-12.30 am Treceability and Measurement Condition

Uncertainty of the Results and Traceability

Traceability of Equipment: Calibration, “History” of Usage, Long-term Performance, and System Suitability

12.30–1.30 pm Lunch

Workshop 07: Inter-laboratory Quality Control Measures

1.30-2.45 pm ISO guides and standards related to Proficiency Testing (PT).

PT project planning.

PT materials preparation, homogeneity test, stability test.

PT materials characterization, assignment of property values and uncertainties.

Performance indicators and assessment.

PT results reporting.


3.00-5.00 pm Group work 6.


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Workshop 04: Internal Quality Control for Laboratories: Method Validation

9.00-10.30 am Internationally Recognized Method Validation Practices

Validation of Methods by Inter-laboratory Study

Single-laboratory' or 'In-house’ Method Validation


10.45-12.30 am Performance Characteristics of the Method.

Internal Quality Control Requirements to Method Validation.

Application of Control Charts

Measurement Uncertainty and Method Validation

Verification of the Performance of the Method during its Regular Use

Adaptation of a Validated Method

12.30–1.30 pm Lunch

1.30-2.45 pm Precision and Trueness Study

Practical Consequences of Variability of the Results - Compliance with Regulatory Limits

Possible Action to Reduce Uncertainty

Optimisation of Testing Strategy


3.00-5.00 pm Group work 7.


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DAY 7 25 NOVEMBER

Workshop 04: Internal Quality Control for Laboratories: Sampling

9.00-10.30 am Sampling Variability, Uncertainties in Sampling

Sampling Strategies for Various Types of Analysis

Statistical Sampling, Quality Assurance in Sampling


Workshop 04: Internal Quality Control for Laboratories: Calibration

10.45-12.30 am Quality Control in Instrumental Analysis

Errors in Straight Line Calibration Graphs

Unweighted and Weighted Regression

12.30–1.30 pm Lunch

EUGENIA SOBOLEVA, DR.

Workshop 08: Project Management: Implementing Quality Management System in Laboratories

1.30-2.45 pm Project Definition and characteristics, Key Project Factors

Planning the Project

Analysis of Organisation Structure and Processes

System Development and Design

Process Categorisation, Types of Processes

Project Implementation, Management by Quality Objectives

Project Control: Project Roles and Responsibilities, WBS

Team Work during the Project

Effective Communication with Laboratory Stakeholders




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9.00-10.30 am International Accreditation Networks

Legal and Regulatory Aspects

National and International Legislation

Accreditation Body Requirements


10.45-12.30 am Accreditation Standards and Guidance Documents; Subsequent Drafts and Valid Revisions

Requirements of ISO 19011 standard

Accreditation and Certification, Ensuring Impartiality

Principle-based Performance Requirement

12.30–1.30 pm Lunch

1.30-2.45 pm Audit Planning and Preparation

Roles and Responsibilities of Assessor, Auditee and Client

Documentation and Checklists

Internal Audit and External Audit

Combined System Audits, Joint Audits

Control of Quality Records

Audit Programme Review and Monitoring




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9.00-10.30 am Audit Process Activities

Reporting, Follow up and Corrective Action


10.45-12.30 am Psychological Aspects of Audit

Requirements to Laboratory Assessors

Communication during Audit Process

Act – Observe – Analyse – Learn

Training for Quality Managers and Assessors

Maintenance of Qualification of Assessor

Evaluation Process

12.30–1.30 pm Lunch

1.30-2.45 pm Group work 10 – Role-play



9.00-10.00 am Written Examination: Multiple-choice Questions

9.00-10.00 am Oral Examination: Group Work, Presentations

11.00–11.30 Coffee break

11.30-1.00 pm Oral Examination: Group Work, Presentations (continues)

1.00–2.00 pm Lunch

2.00-3.30 pm Announcement of Examination Results

Official Closing Ceremony.


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REGISTRATION AND PAYMENT

Attendance fees (20% VAT is NOT included)

Complete 10 days training including examination € 2.750,-

Daily fee* € 385,-

* All workshops can be attended selectively. Certificates of completion are issued to the participants attended selective workshops. EOQ certificates are awarded to the participants attended full training program and upon successful completion of the examination. EOQ certificate is subject to EOQ rules and regulations.

The fee includes lunch, coffee breaks and refreshments

Training venue

Vienna Downtown, City Space, Goldschmiedgasse 10/303, 1010 Vienna Austria

www.city-space.at.

Invitation letter for visa support is provided on demand after confirmation of payment is received.

The registration is open until 3 of October 2014.

Payment fee must be transferred to: Quality Austria GmbH. Uni Credit Bank Austria AG BLZ 12000, Konto Nr. 50670 594 501 IBAN AT 91 1200 0506 7059 4501 SWIFT BKAUATWW

Transaction purpose: Laboratory Quality Manager and Assessor, November 2014 The Registration is completed when the bank transfer is certified by the local bank Full refund will be provided for the cancellation received more than thirty working days before the commencement of the course. A refund of 50% will be provided for cancellations received two weeks before the start of the course. Quality Austria reserves the right to cancel or change a training course. Registered delegates will be informed and their training course fee refunded.


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REGISTRATION FORM

I will attend the following training:

Training title Training date Participant information:

Title First name Last name Date of birth Place of birth Company Address Country Telephone Fax E-Mail

Invoicing address (if different from the address indicated above):

Company Address Country Telephone Fax E-Mail

Please return to: ITA L.L.C. - International Training Associates Vienna DC, Wagramerstrasse 4/412 A-1220, Vienna, Austria, Europe Tel: (+43 650) 247 37 61 Fax: (+43 1) 260 57 23 E-mail: [email protected]

[email protected]


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TRAINERS

Arpad Ambrus, Dr. Prof. Arpad Ambrus got his PhD in Chemistry. He started to work on various aspects of residue analysis in 1969. His major area of interest included elaboration of cost effective multi residue procedures, estimation of uncertainty of sampling and sample processing, internal quality control of analytical processes, development of guidelines for single laboratory validation of methods, and introduction and application of GLP principles in pesticide residue laboratories. He had been the technical scientific manager of analytical laboratories in Hungary over 25 years, and spent several years in developing countries as FAO expert. For seven years he lead analytical quality training program at FAO/IAEA Training and Reference Centre in Vienna. Currently he is responsible for implementation of State Food Safety Laboratory Testing Program in Hungary.

Paul Doherty, Dr. Paul Doherty has worked in the UK and International Industries for 19 years. For several years Paul was a laboratory quality manager at the United Kingdom Atomic Energy Authority. For seven years he managed the chemical analysis service for nuclear safeguards for the International Atomic Energy Agency. With both UKAEA and the IAEA he was involved in implementation of Quality Management Systems. Paul has considerable international experience and has assisted in QMS implementation in over 10 different countries. Since 2003 he has worked as a quality management consultant. Currently Paul is a director of PDQM Limited.

Eugenia Soboleva, Dr. For more than ten years Dr. Eugenia Soboleva was leading the laboratory activities related to monitoring of organic residues and contaminants in food and environmental samples. She conducted and supervised method development and validation for pesticides, toxins, Dioxins, PCBs, phenols, phthalates and other contaminants. Dr. Eugenia Soboleva was also responsible for implementing Quality Management Systems and Good Laboratory Practices in testing laboratories. She was a manager of many multidisciplinary international research programmes in the area of food and environmental safety at FAO/IAEA. Currently she is a manager of Laboratory and GAP Program at Quality Austria - the leading Training and Certification Company in Austria.

Irene Zimpernik, Dr. Irene Zimpernik has extensive experience in the field of laboratory diagnostics including veterinary, food and feed analysis, mycology and mycotoxins, as well as hygiene controls and molecular biology. She is the head of the laboratory and research department for serology, microbiology, pathology and hygiene, performing and supervising projects in cooperation with international laboratory partners and reference institutes all over Europe. For 8 years she has been a quality manager and trainer of laboratory staff with a wide range of responsibilities including the implementation of QMS in veterinary diagnostic and food safety laboratories. Dr. Irene Zimpernik is a highly qualified lecturer and quality management consultant. She has established management systems and conducted ISO 9000 and 17025 audits in numerous laboratories and enterprises.


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OTHER SERVICES

IN-HOUSE SEMINARS

Quality Austria also provides in-house customized training, allowing you to organise training for your staff conveniently and cost-effectively at your facility. In-house training can be adapted to meet your organization's specific needs. Combination of LQMAT Workshops 01-09 and Specific Seminars SS01-SS08 is possible. Additionally hands on experiment and demonstrations can be carried out on your instrumentation.

SS01 Software support and IT-solutions for Quality Documentation

SS02 Uncertainties in Qualitative Testing and Confirmation

SS03 Internal QC Measures in GC/HPLC Analysis of Trace Residues and Contaminants

SS04 Persistent Organic Pollutants (POPs): Sampling, Analysis and Control

SS05 Pesticide Residues: Analysis, QA/QC Measures and Estimation of Uncertainty

SS06 QA/QC Measures in Pesticide Formulation Control

SS07 Quality Control in Microbiological Testing

SS08 QA/QC in Testing Radioactive Materials

SS09 Quality Management System for Food Industry

CONSULTANCY

Pre-assessment for accreditation and gap analysis

Coaching in Quality Documentation Development

Use of IT-solutions for Quality Management

Application of Quality Control Measures

Uncertainty Measurement

Selection of appropriate PT scheme

Organization of Inter-laboratory Comparison

Support in procurement for analytical and testing laboratories: equipment, reagents, certified reference materials, standards, and glassware

Coaching in Internal Audits

For more information and registration please contact:

ITA-International Training Associates Vienna DC, Wagramerstrasse 4/412 A-1220, Vienna, Austria, Europe Tel: (+43 650) 247 37 61 Fax: (+43 1) 260 57 23 E-mail: [email protected]

[email protected]


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ITA L.L.C. – Innovation and Training Associates

ITA L.L.C. was established in 2002 to provide the most competitive advice and training jointly with international network of premium partners. ITA main streams of activities include:

Training – training content development and training, organisation of study tours. Training on product certification schemes required on different markets, system certification for various industry branches, management seminars including knowledge management, branding and business strategies.

Investment - consulting on international strategic alliances, due diligence reports, product penetration strategies, supply chain management for international markets such as Russia, CIS, Asia and Latin America.

Export strategies - support in attaining product certification in the EU (CE - seal), Russia and CIS countries, and advisory services in local branding and distribution strategies.

Quality Austria - Certification, Evaluation and Training Ltd.

Quality Austria is accredited for certification for people, management systems and products by BMWFJ – member of EA, ILAC and IAF. It is a partner of IQNet, EOQ and EFQM.

Quality Austria is the leading certification and evaluation company in the fields of quality, environmental, safety management. More than 25 000 Certificates are issued until now.

Quality Austria offers 500 courses a year. Participants from around 8.700 companies from all sectors regularly attend Quality Austria courses.

European Organization for Quality, EOQ

The EOQ is the European interdisciplinary organization striving for effective improvement in the sphere of quality management as the coordinating body and catalyst of its Full Member Organizations (FMOs).

The EOQ was established in 1956 and its present membership is comprised of 34 national European quality organizations, as well as institutions, companies and individuals from all over the world.