Dr Joachim Ermer
Ermer Quality Consulting
Referierende
Dr Christopher Burgess
Burgess Consultancy
Shortcuts: compact learning units of 1–3 hours – perfect for a quick overview or a focused deep dive into a specific topic. Book online, receive access within minutes and benefit from 7 days of on-demand availability, giving you maximum flexibility in your day-to-day work.
Compact. Flexible. Immediately available.
Zielgruppe
- 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
Zielsetzung
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.
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.
Programm
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.
Weitere Informationen
The purchase process for the GMP & GDP Shortcuts is handled via the sales platform Digistore24 (www.digistore24.com). Please understand that it is not possible to place an order on account in this case.
By clicking the “Book now” button at the top right, you will be redirected to Digistore24. After successful payment, you will automatically receive a confirmation email from Digistore24 and an email from Memberspot (our streaming provider) asking you to register.
Afterwards, you will have access to the purchased video for 7 days.
Please note: The booking is valid only for the registered participants. The use by other persons is prohibited and constitutes an infringement of copyright.
Presentation and certificate:
Starting from the purchase date, the presentation will be available for you to download in Memberspot for 7 days. Afterwards, the participants can download a certificate of attendance.
Contacts
Questions regarding content:
Dr Markus Funk, +49 6221 84 44-40, funk@concept-heidelberg.de
Questions regarding organisation:
Mr Niklaus Thiel, +49 6221 84 44-43, thiel@concept-heidelberg.de
Duration of the shortcut: 1h 45m
Recorded in September 2024
Please note:
When you click on “Register”, you will be redirected to www.digistore24.com. Once your payment has been successfully completed, you will immediately receive 7 days’ access to the Shortcut you ordered via the Memberspot streaming platform. We kindly ask for your understanding that payment by invoice is not possible.
When you click on “Register”, you will be redirected to www.digistore24.com. Once your payment has been successfully completed, you will immediately receive 7 days’ access to the Shortcut you ordered via the Memberspot streaming platform. We kindly ask for your understanding that payment by invoice is not possible.
Teilnahmegebühr
| Regular Fee*: | € 399,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
Aufzeichnung/weitere Termine nicht verfügbar
Aufzeichnung/weitere Termine nicht verfügbar
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E-Mail: info@concept-heidelberg.de
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