Statistical Simulations for Enhanced Understanding of Analytical Performance - Webinar Recording

Course No. 21367



Dr. Joachim Ermer

Dr. Joachim Ermer

Ermer Quality Consulting

Dr. Christopher Burgess

Dr. Christopher Burgess

Burgess Analytical Consultancy


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 new ICH 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 Details

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Timing and Duration:
When you register for the on demand Training course or webinar you can decide at what date you want to follow the training course online. For a 1-day training course you will have 2 days in which the stream is available (for 2-day training course 3 days and for a 3-day training course 4 days). Within in this timeframe you can start & stop the stream according to your needs.

In time before the scheduled date (your desired date) you will receive an e-mail from us with a link for direct participation as well as your log-in data.

Please be aware: The recording does not include the Q & A sessions.

Training Course Documentation and Certificate:
The presentation will be made available as PDF-files via download during the online training course. After the successful completion of the online training, you are able to download the certificate of attendance.


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.
Recording from 25 September 2023
Duration of the recording: 1 hour 45 minutes

ECA-Member*: € 249,-
Regular Fee*: € 299,-

(All prices excl. VAT). Important notes on sales tax.

* also payable by credit card
American Express Visa Mastercard

Further dates on-site
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Tel.: +49 6221 8444-0

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