SEMINAR OVERVIEW LE290
Advanced GLP: Uncertainty Measurement & International Standards

Seminar Title
Advanced GLP: Uncertainty Measurement & International Standards 

Seminar Date/ Venue
May 10-14, 2009/Safari Meeting Room, Samaya Hotel, Dubai, UAE

Seminar Reference
LE290

Seminar Duration/Credits
Five days/3.0 CEUs

Seminar Description
Good laboratory practice means different things to different people. This seminar covers the advanced topics in Good Laboratory Practice (GLP). All the practices that ensure that laboratory testing is planned, performed, monitored, recorded and reported in an organised and controlled manner, will be discussed in general and the Uncertainty Measurement (GUM) in particular. 

The seminar addresses the requirements of EN ISO / IEC 17025: 2005 General Requirements for the Competence of Testing and Calibration Laboratories as well as the common requirements of GLP Compliance (OECD, USA, Canada, Europe & Japan) as applicable to QC/QA/Production Control Laboratories. The different GLP standards set out the requirements for technical competence and proper management of the analytical laboratories. The standards usually cover a variety of topics, that will be covered during this seminar: Laboratory Organization; Personnel; Safety Assurance; Laboratory Facility; Testing and Measuring Equipment; Apparatus and Reagents; Test Methods and Procedures; Calibration; Samples and Test Data Storage, Inspection, Assessment and Uncertainty Measurement (UM). The seminar will also discuss the requirements to be met by a laboratory supporting its organisations quality system to the ISO 9000 series of standards. 

TThe seminar provides training of the Good Laboratory Practice (GLP) for personnel of laboratories who wish to produce test results that are fit for the purpose and which would stand up to the scrutiny. Obviously, the primary objective of the GLP is to ensure the generation of high quality data. Statistical tools play an important role in GLP to calculate the Uncertainty Measurement. This seminar will focus on the latest techniques and standards developed to measure the uncertainty of the data. The Guideline for Uncertainty Measurement (GUM) will be introduced in a simple way. Every effort is made in this seminar to eliminate unnecessary complications, to apply the GUM at its simplest level and to take away apparent mystery. Participants who have never drawn up uncertainty budgets before usually develop the required skill well before the end of the seminar. Others who seek explanations of GUM complexities obtain clarifications expressed in simple terms. Measurement uncertainty problems are solved by brainstorming methods so as to generate interaction by all participants. The seminar will use the Statistical Process Control (SPC) module as a tool to validate the uncertainty measurement. It covers control charts and their applicability to uncertainty before covering a step-by-step process of calculating uncertainty for a typical application. Methods of reporting uncertainty, the uncertainty budget and applicable standards and guidelines for expressing measurement uncertainty are covered in some detail. Successful completion of this seminar will enable participants to understand, evaluate and express measurement uncertainty.

Seminar Objectives
Upon the successful completion of the seminar, participants will be able to:-

• Understand the quality assurance in laboratory and the importance of ISO 17025 system

• Describe what is the Good Laboratory Practice (GLP) and its importance in modern laboratories and in technology transfer

• Determine the cost of GLP non-compliance

• Know the various GLP standards and regulations that set out the requirements for technical competence and proper management of analytical laboratories

• Identify the common requirements of GLP compliance as per OECD, the USA, Canada, Europe and Japan

• Explain the differences between the USA and OECD regulations and identify which system is suitable for your laboratory

• Aware of the critical GLP compliance issues

• Describe the GLP requirements related to organization, personnel, facilities, equipment, operations, testing, control, protocols, records and reports

• Know the scope, field of application, components & sources of uncertainty and be able to learn how to conduct analytical measurement & experimental studies of method performance

• Review & improve the process of measurement uncertainty estimation and be able to analyze the specification of the measurand

• Identify uncertainty sources and employ the process of quantifying uncertainty

• Carry-out the process of calculating the combined uncertainty and be able to review the procedure on reporting uncertainty

• Understand the Statistical Process Control (SPC) and identify its applications

• Know the various methods of controlling measurement processes, production processes and equipment attributes

• Estimate the parameter intervals and apply safety assurance in your laboratory
   

Training Methodology
This interactive training seminar includes the following training methodologies as a percentage of total tuition hours:-

50% Lectures
30% Workshops, Group Work & Practical Exercises
20% Videos & Software
 

Who Should Attend
This seminar is aimed at all staff of Laboratories. This includes laboratory managers, superintendents, supervisors, doctors, physicians, chemists, analysts, officers, coordinators and technicians. R&D and government statutory employees are encouraged to attend this outstanding seminar. Further, this seminar is very important for QA/QC employees and Third-Party Inspection and certification companies.

Seminar Certificate
 

1. Attendance Certificate: Haward Technology certificate will be issued to all attendees completing minimum of 75% of the total tuition hours of the course..

2. Competency Certificate: This certificate will be issued to every participant who successfully completed the whole seminar and passed the exams at the end of the seminar..
    

Seminar Accreditation
Haward Technology’s courses/workshops/seminars meet the professional certification and continuing education requirements for participants seeking Continuing Education Units (CEUs) in accordance with the rules & regulations of the International Association for Continuing Education & Training (IACET). IACET is an international authority that evaluates programs according to strict research-based criteria and guidelines. The CEU is an internationally accepted uniform unit of measurement in qualified courses of continuing education. 

Haward Technology has been approved as an Authorized Provider by the International Association for Continuing Education and Training (IACET), 1760 Old Meadow Road, Suite 500, McLean, VA 22102, USA. In obtaining this approval, Haward Technology has demonstrated that it complies with the ANSI/IACET 1-2007 Standard which are widely recognized as standards of good practice internationally. As a result of our Authorized Provider membership status, Haward Technology is authorized to offer IACET CEUs for its programs that qualify under the ANSI/IACET 1-2007 Standard.

Haward Technology Middle East will award 3.0 CEUs (Continuing Education Units) for participants who completed the total tuition hours of this program. One CEU is equivalent to ten Professional Development Hours (PDHs) or ten contact hours of the participation in and completion of Haward Technology programs. A permanent record of a participant’s involvement and awarding of CEU will be maintained by Haward Technology. Haward Technology will provide a copy of the participant’s CEU Transcript of Records upon request.

Seminar Fee
US $ 3,750 per Delegate. This rate includes Participant’s Pack (Folder, Manual, Hand-outs, etc.), buffet lunch, coffee/tea on arrival, morning & afternoon of each day. 

Accommodation
Accommodation is not included in the seminar fees. However, any accommodation required can be arranged by Haward Technology at the time of booking.

Seminar Director
Professor Willem De Beer (UK), PhD Chem... More

Course Coordinator
Lily Hijazi, Tel: +971-2-44 88 301, Fax: +971-2-44 88 302, Email: lily@haward.org