Statistical Simulations for Enhanced Understanding of Analytical Performance - Live Webinar

Statistical Simulations for Enhanced Understanding of Analytical Performance - Live Webinar

Course No 20052

This webinar is included free of charge for all participants of the ECA course “Practical Statistical Tools for Analytical Laboratories” on 16/17 November 2022 in Heidelberg. If you decide to book the course in Heidelberg after attending the webinar, the webinar fee will be credited.

Costs

ECA-Member*: EUR 249,--
Non ECA Member*: EUR 299,--

(All prices excl. VAT)

* also payable by credit card American Express Visa Mastercard

If you have any questions, please contact us:
Tel.: +49 (0)6221 / 84 44 0 E-Mail: info@gmp-compliance.org

Speakers

Dr Christopher Burgess
Dr Joachim Ermer

Background

A comprehensive understanding of the performance of an analytical procedure is a key element in the enhanced (Quality-by-Design) development approach described in the ICH Draft Guideline Q14 “Analytical Procedure Development”, but is also beneficial in more traditional approaches to method development and validation. Besides the identification and (as far as possible) elimination of systematic bias (thus ensuring accuracy), an appropriate knowledge of the random variability (common cause variation) is essential, as this error type contributes to all other performance characteristics.

Having established a reliable knowledge of the respective precision, statistical simulations can facilitate to evaluate the consequences to other performance attributes or investigations, such as calibration models, design of precision or transfer studies, reportable values etc. This approach allows to perform a large number of (simulated) “experimental” investigations, to gain a “feeling” on the interplay of precision, number of determinations, as well as acceptance criteria.

Target Group

  • Analytical laboratory managers and their colleagues charged with the day to day management and evaluation of laboratory data throughout the lifecycle, i.e. in method development, validation, transfer, specification setting, batch release and stability, continuous performance verification and change control.
  • QA, manufacturing and regulatory affairs professionals

Technical Requirements

We use Webex Events for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. Webex is a standard nowadays and the necessary installation is fast and easy.

Programme

The participants will learn what statistical simulations are and how they can be applied to relevant questions in pharmaceutical analysis, such as
  • Expected spread of data, standard deviations, means
  • Interplay of standard deviation, number of determinations, and specification Limits
  • Link between variability contributions of precision levels and expected mean difference (e.g. for transfer of analytical procedures)
The participants will receive an Excel file with simulation worksheets, which will be explained in the webinar and which can be used later for own applications.

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