Dr Joachim Ermer
Ermer Quality Consulting
Referierende
Shortcuts: Compact learning units of 1–3 hours. 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.
Zielgruppe
This shortcut is intended for anyone who deals with OOT results in the analytical laboratory or wants to gain an overview of the topic. This includes, for example, professionals working in:
- Incoming goods control,
- Control of finished drug products,
- Analytical development,
- Chemical and food industry,
- Contract laboratories.
The shortcut is also aimed at Qualified Persons (QPs), Heads of Quality Control, laboratory managers, and anyone responsible for the evaluation and investigation of OOT results in stability studies.
Zielsetzung
This shortcut provides a general introduction to Out-of-Trend (OOT) results in stability studies and their relevance for the proactive identification of potential OOS results. It explains the importance of recognising atypical trends and distinguishing them from expected variability in stability data. Participants will gain an overview of commonly used approaches for evaluating OOT results and learn about the role of appropriate OOT limits in the assessment and investigation process.
Programm
The following topics are addressed:
Out-of-Trend Results
- Submission Stability Studies
- Ongoing Stability Studies
Investigation Approaches
- Visual Inspection & Point Estimates of Slope
- Prediction Interval
- Regression Control Chart Method
- Slope Control Chart Method
- By-Time-Point Method
- Cluster Approach – NV Organon
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:
Ms Sonja Nemec, +49 6221 84 44-24, nemec@concept-heidelberg.de
Duration of the Shortcut: 1h 05m
Recorded in September 2026
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.
Teilnahmegebühr
| Reguläre Teilnahmegebühr*: | € 399,- |
Alle Preise zzgl. MwSt. Wichtige Hinweise zur Umsatzsteuer.
* auch unkompliziert per Kreditkarte bezahlbar
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E-Mail: info@concept-heidelberg.de
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