Training Programme Laboratory Quality Manager

Training Programme
Laboratory Quality Manager and Laboratory Assessor
18 – 29 May 2015
Vienna, Austria
Accredited by BMWFW – member of EA and ILAC
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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Accredited by BMWFW – member of EA and ILAC
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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Accredited by BMWFW – member of EA and ILAC
DAY 1
18 MAY 2015
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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DAY 2
19 MAY 2015
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
10.30–10.45 am
Coffee break
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
2.45–3.00 pm
Coffee break
3.00-5.00 pm
Group work 2: practical exercises
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DAY 3
20 MAY 2015
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.
10.30–10.45 am
Coffee break
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.
2.45–3.00 pm
Coffee break
3.00-5.00 pm
Group work 3
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DAY 4
21 MAY 2015
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
2.45–3.00 pm
Coffee break
3.00-5.00 pm
Group work 5: practical exercises
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DAY 5
9.00-10.30 am
22 MAY 2015
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.
2.45–3.00 pm
Coffee break
3.00-5.00 pm
Group work 6.
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DAY 6
25 MAY 2015
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
10.30–10.45 am
Coffee break
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
2.45–3.00 pm
Coffee break
3.00-5.00 pm
Group work 7.
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DAY 7
26 MAY 2015
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
10.30–10.45 am
Coffee break
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
2.45–3.00 pm
Coffee break
3.00-5.00 pm
Group work 8
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DAY 8
27 MAY 2015
Workshop 09: Laboratory Audit
9.00-10.30 am
International Accreditation Networks
Legal and Regulatory Aspects
National and International Legislation
Accreditation Body Requirements
10.30–10.45 am
Coffee break
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
2.45–3.00 pm
Coffee break
3.00-5.00 pm
Group work 9
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DAY 9
28 MAY 2015
Workshop 09: Laboratory Audit
9.00-10.30 am
Audit Process Activities
Reporting, Follow up and Corrective Action
10.30–10.45 am
Coffee break
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
2.45–3.00 pm
Coffee break
DAY 10
29 MAY 2015
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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Accredited by BMWFW – member of EA and ILAC
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 1 of April 2015.
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, May 2015
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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Accredited by BMWFW – member of EA and ILAC
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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Accredited by BMWFW – member of EA and ILAC
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.
Abdul Ghani Shakhashiro, MSc. Eng.
Abdul Ghani Shakhashiro has 30 years of experience in environmental, pharmaceutical, food and nuclear
industries. For 20 years he worked at Canadian and International companies. For several years Abdul
was responsible for the office of Analytical Quality Control Services (AQCS) at Seibersdorf Laboratories of
the International Atomic Energy Agency in Austria. For eight years he was responsible for preparation
and production of certified reference materials characterized for organic, trace elements and
radionuclides. He was organizing worldwide proficiency tests which attracted more than 400 laboratories
to evaluate and improve analytical performance. Abdul was extensively involved in implementation of
regional projects for auditing and implementation of integrated quality management systems ISO-9000,
ISO-14000 and ISO-17025 of 15 countries in Latin America and the Middle East regions. Since 2013 he
has worked as a director of IARMA Limited Vienna office.
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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 SS01SS08 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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Accredited by BMWFW – member of EA and ILAC
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 Training, Certification and Evaluation GmbH
Quality Austria Training, Certification and Evaluation GmbH is your competence partner for
Integrated Management Systems in the fields of Quality, Environment and Safety and
Industry Standards as well as Business Excellence. The services provided by Quality Austria
range from trainings in the field of international management trends and techniques via
certification of management systems according to international standards and regulations and
national guidelines and directives and assessments acc. to the EFQM Excellence Model to
awarding the Austria Quality Seal. The Austrian Excellence Award will be presented to Austrian
organisations in cooperation with the Federal Ministry of Science, Research and Economy.
Quality Austria is accredited by the Federal Ministry of Science, Research and Economy and
has numerous international registrations and accreditations.
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.
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Accredited by BMWFW – member of EA and ILAC