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Labcompliance On-line Audio Seminar

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On-line Audio Seminar 386

Measurement Uncertainty in Chemical Analysis

With tools to comply with ISO17025, USP Chapter 1220 and FDA expectations

October 5, 2017

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Measurement and documentation of analytical uncertainty is a requirement of ISO 17025 and other quality chapters such as USP 1220. FDA regulations don't include the word uncertainty directly. However, having good information on the accuracy, possible errors and uncertainty of analytical  data is a prerequisite of Good Analytical Practices. And inspectors are familiar with measurement uncertainty because  FDA laboratories follow their procedures for measurement uncertainty to comply with their own regulations. Despite of the importance of measurement uncertainty laboratories have many questions.

Frequent questions are

  • What is the difference between inaccuracy, analytical error and measurement uncertainty
  • Why do we need to care about measurement uncertainty
  • What are specific requirements of ISO 17025
  • What exactly are the expectations of FDA inspectors
  • Do we also need uncertainty evaluation for standard and ad-hoc methods?
  • What are most common sources for uncertainty
  • How to best evaluate measurement uncertainty
  • Can we use intermediate precision for measurement uncertainty?
  • Is there any impact of uncertainty limits on out-of-specification results?
  • Are there any official acceptance limits for analytical measurement uncertainty
  • How to handle multiple uncertainties 
  • How to report measurement uncertainty estimates and results?

How does the audio seminar help:

Questions will be answered by Dr. Ludwig Huber in a new interactive audio seminar. During the seminar strategies and procedures will be presented on how to develop, document, maintain and update User Requirements. An extensive list of reference material like SOPs, templates and examples will help immediate and cost effective implementation.

During the interactive presentation you learn about:

  • Requirements and expectations from ISO 17025 and  FDA
  • Other official standards and guidelines
  • The importance of measurement uncertainty for the quality of analytical data
  • Analytical uncertainty vs. inaccuracy and error
  • Comparison of four alternative approaches
  • Identifying uncertainty sources
  • Setting specifications for uncertainty
  • The uncertainty measurement process from sampling to reporting: flow diagram
  • Example procedure for measurement uncertainty
  • Quantification of individual sources
  • Evaluation of uncertainty for ad-hoc methods
  • Combining multiple uncertainties
  • Reporting for ISO 17025 and FDA
  • Impact of uncertainty results on product specifications and out-of-specification results

Get 10+ Documents To Do it Right The First Time:
download from special seminar website

  • SOP:
    - Measurement Uncertainty in Chemical Analysis
  • Gap analysis/checklists:
    - Measurement Uncertainty in Chemical Analysis
  • Forms
    - Reporting Individual Components Contributing to Measurement Uncertainty
    - Documenting Recovery Studies for Uncertainty Evaluation
    - Documenting Combined Standard and Expanded Uncertainties
    - Reporting Analytical Results with Expanded Uncertainty

Guides to Quality Documents (links)

  • Guide to the Evaluation of Measurement Uncertainty - eurolab
  • EUROLAB: Measurement uncertainty revisited - Alternative approaches to uncertainty evaluation. Technical Report No. 1/2007 (www.eurolab.org)
  • LGC/VAM: Development and Harmonisation of Measurement Uncertainty Principles Part(d): Protocol for uncertainty evaluation from validation data (www.vam.org.uk)
  • EURACHEM/CITAC: Use of uncertainty information in compliance assessment (2007)
  • APLAC - Interpretation and guidance on the estimation of uncertainty of measurement in testing (www.aplac.org)
  • AALA: G104 – Guide for Estimation of Measurement Uncertainty in Testing
  • ISO/BIPM Guide: Uncertainty of Measurement
  • Guidelines for Evaluating and Expressing the Uncertainty of NIST Measurement Results
  • Practical Examples on Traceability, Measurement Uncertainty and Validation in Chemistry
  • A practical guide to analytical method validation, including measurement uncertainty and accuracy profiles

Who should attend?

  • QA managers and personnel
  • Analysts and lab managers
  • Validation specialists
  • Training departments
  • Documentation department
  • Consultants
  • Testing laboratories working under ISO 17025
  • Analytical laboratories working under USP 1220
  • Pharmaceutical development and QC labs

Date and time

October 5, 2017
North America: ET 11 a.m.  CT 10 a.m. PT 8 a.m., Europe: CET
5 p.m. (Paris/Berlin)
Check: www.timeanddate.com/worldclock/ for you local time.
The seminar will last one hour

How to order

Pick one of the options in the table that fits your needs.

Standard offer

  • Single person
  • From the convenience of your desk

US$ 249.-
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'Site' offer

  • Multiple persons - single site and phone line
  • Meet in a seminar or conference room

US$ 399.-
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Recorded seminar - CD

  • Get the CD in your mail
  • Useful if you can/could not attend the on-line seminar. Order includes all reference material.

US$ 399.-
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Recorded seminar - Download Version

  • Download from the Internet
  • Listen and learn whenever you want, wherever you want. Order includes all reference material.

US$ 399.-
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Special offer for Labcompliance Usersclub Members

  • Order includes all reference material.
  • for Usersclub information and registration, click here

from US$ 149.-
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About audio seminars

Online audio seminars are presented over the phone. During the live presentation attendees can:

  1. Study the printed slide material
  2. Watch the slides on a computer
  3. Watch the slides on a video screen in a seminar room
  4. Ask questions through email and web form

About Dr. Ludwig Huber

Dr. Ludwig Huber is the editor and author of Labcompliance. He has been conducting over 300 web and audio or video based seminars since 15 years and and he has given multiple presentations mainly on GLP/GMP, 21 CFR Part 11 and Validation around the world. This included seminars, workshops and presentations for the US FDA, SFDA, KFDA, HSA, ISPE, PDA, PIC/S and several national health agencies.

Dr. Ludwig Huber is a frequent presenter at IVT conferences and has been awarded as the 'Presenter of the Year' out of 170 speakers. This photo is from IVT's conference on Network Qualification with Ludwig Huber as plenary speaker.

Dr. Huber has published several books related to validation and compliance, for example: Validation of Computerized Analytical and Networked Systems. He was or still is a member of several committees, e.g., of the GAMP® Special interest group (SIG) on Laboratory Computers, PDA Part 11 task force, IVT task force on network infrastructure qualification and the European Compliance Academy. He frequently visited FDA in Rockville, VA, and participated in panel discussions with FDA professionals. For feedback from attendees of seminars and  for other information on Dr. Ludwig Huber, click here.