Westgard Workshops 2008

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Validation and Verificiation: Best Practices for assessing performance of new tests

This workshop was held on October 17th. (Please inquire about private workshops.)

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Basic Method Validation 2008 October 10th, 2008 8:00 am - 4:00 pm Abbott Park, Chicago IL  Supported in part by an educational grant from Abbott Diagnostics October 17th, 2008 8:00 am - 4:00 pm Rochester, MN Supported in part by an educational grant from Olmsted Clinic  Registration:  $395.00 Additional participants from the same organization register at a further discount. Call for details. Each Participant Receives: A copy of Basic Method Validation, Third edition Workshop handouts for all presentations, plus supplementary material Internet access to reference material at Westgard Web Workshop Location: October 17th: Olmsted Clinic, 1650 Fourth Street SE Rochester, MN 55904 Travel and hotel directions Instructors:  James O. Westgard, PhD

Method Validation and Verification Best Practices for assessing performance of new methods October 17th, Olmsted Hospital, Rochester, MN  In conjunction with the release of the third edition of the essential laboratory reference Basic Method Validation, Dr. James O. Westgard is presenting two one-day workshops on this important subject. Since the 2003 "Final" CLIA rule, CMS requires that US Laboratories must evaluate and validate all new non-waived methods. The complex task of determining linearity, imprecision, inaccuracy, correlation, interference, detection limit and reference range for new methods now falls on the laboratory. Given worsening staff shortages and increasing cost pressures, laboratories might find themselves crippled by this new burden. At the Validation and Verification workshop, participants will learn a logical, practical solution to this problem. Step-by-step techniques will be explained. Tools will be demonstrated that speed and simplify calculation. More importantly, the logic of method validation will be discussed so participants understand why studies are performed and what the results mean. This workshop will cover more than just the bare minimum studies required for compliance. Newly emerging standards and approaches will also be discussed. The new CLSI EP15 guideline will be explained - an abbreviated but robust approach to method validation. Also, ISO 15189 and the measurement uncertainty approach will be discussed. Finally, Dr. Westgard will advise you on how to customize and optimize method validation studies for your laboratory. Workshop Instructors: James O. Westgard, PhD, FACB, Emeritus Professor, Department of Pathology and Laboratory Medicine, University of Wisconsin, President, Westgard QC Inc., Madison WI. Dr. Westgard, author of the popularly-known "Westgard Rules", will lead this training event. More than 30 years ago, Dr. Westgard and colleagues virtually invented method validation for laboratory instruments. With decades of experience, there is no better teacher of proper statistical technique. Sten Westgard, MS, Director of Client Services. Sten Westgard has edited and published the Basic Method Validation and Basic QC Practices reference manuals through three editions. He has created and administrated online training programs for laboratory professionals for more than a decade. He also manages Westgard Web. What you will learn In a relaxed, retreat-style setting, you will learn how to: How to perform the following studies linearity, reportable range imprecision comparison of methods interference and recovery detection limit reference range transference Six Sigma Method Decision Utilize practical statistics tools that allow easy entry, calculation and interpretation of validation data Assess the "latest" CLIA method validation regulations Master the changes to the method validation requirements of JC and CAP Learn about the new CLSI guidelines EP15 - as well as coming guidelines that will affect future validation studies Identify the best statistical tools for method validation Benchmark your method validation results against the quality being achieved in laboratories nationwide and worldwide Improve the efficiency, effectiveness, and profitability of your laboratory Workshop Program: morning coffee Method Validation: The why, what, when, where and how! Approach to MV and Experimental Plan break Experimental procedures Data analysis tools lunch Statistical sense and sensitivity Judging acceptability from experimental results break CLSI EP15: Verifying a manufacturer's claims Assessing Sigma-capability from manufacturer claims Method Validation in the Real World Reserve your Seat at the Workshop!

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 Should YOU Attend?

Do you have to evaluate, validate, or verify the performance of new methods for the laboratory?

Are you responsible for assuring the quality of the processes you perform?

Do you provide services or products to someone who does?

The Westgard Workshops are a unique opportunity for you to gain insights into the New Laboratory Economy. Every laboratory professional can gain something from these training sessions:

• HOSPITAL AND HEALTH SYSTEM ADMINISTRATORS: gain insight into the regulatory requirements and standards that govern non-waived methods. Utilize new tools and advanced techniques to assess method performance and compare them to Six Sigma benchmarks.
• CLINICAL LABORATORY ADMINISTRATORS, PATHOLOGISTS, and PH.DS.: refresh their knowledge of method validation concepts and calculations; update their understanding of what studies to perform; develop new skills and comprehension of quality management systems.
• SECTION SUPERVISORS, COMPLIANCE SPECIALISTS and REGULATORY AFFAIRS MANAGERS: acquire new practical tools to streamline your method validation and quality improvement efforts.
  
• DIAGNOSTIC MANUFACTURERS, R&D, TECHNICAL SUPPORT, and FIELD REPS: understand the environment of your customers and identify areas where you can deliver truly-valued solutions. Utilize Six Sigma to assess product performance and compare to competitor achievements.

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Travel and Hotel Information for the October 17th Workshop at Olmsted Clinic, Rochester, Minnesota:

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About James O. Westgard, Ph.D.:

James O. Westgard, Ph.D., is the internationally recognized QC expert, originator of multirule QC (popularly known as the "Westgard Rules"), and the primary instructor for these workshops.

Dr. Westgard is the Professor Emeritus at the University of Wisconsin Hospital and Clinics. For over forty years, Dr. Westgard has lectured and given workshops on five continents, in dozens of cities; published hundreds of abstracts, papers, chapters, and numerous books; provided QC consulting and advice to manufacturers, hospitals, and government agencies; received awards and honors from the AACC, ASCLS, NACB, the British Association of Clinical Biochemists, and the Australian Association of Clinical Biochemists. Most recently, he received the 2004 Laboratory Public Service National Leadership Award for Lifetime Achievement from the Washington G2 Lab Institute, and the 2005 Improved Quality Processes Award from the Institute for Quality in Laboratory Medicine.

For Dr. Westgard's complete biography, click here.

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