Dr Joachim Ermer
Ermer Quality Consulting
Referent:innen
Zielgruppe
This training is aimed at executives and employees from Quality Control, Quality Assurance, and production who want to gain a better understanding of the GMP requirements as well as current discussions with respect to the lifecycle management of analytical procedures and are interested in practical recommendations for an efficient design, execution, and evaluation of a continuous analytical performance verification.
Zielsetzung
Besides regulatory and compendial expectations, as discussed in the just published draft of a new USP General Information Chapter <1221> “Ongoing Procedure Performance Verification” this Live Online Training provides practical recommendations and orientation for demonstration of the continual suitability of analytical procedures across the analytical procedure lifecycle. In particular, efficient approaches will be presented to extract information and data from routine analysis. This will be illustrated with examples from quality control of chemical drug substances and biopharmaceuticals.
A comprehensive understanding of the real analytical performance is extremely helpful to identify, investigate and evaluate suspect (out-of-trend, OOT) or out-of specification (OOS) results as well as for a continuous process validation.
Background
According to the FDA-Guidance “Analytical Procedures and Methods Validation for Drugs and Biologics“ (2015), it should be continually assured that an analytical procedure remains fit for its intended purpose throughout its application. This includes an ongoing program for routine monitoring of analytical performance data, and the systematic evaluation of changes with the objective to evaluate regularly the need for optimization and revalidation, if needed. These activities belong to stage 3 of the analytical lifecycle management as discussed in the USP General Information Chapter <1220>. The ongoing performance verification is also discussed in the ICH Guideline Q14 “Analytical Procedure Development” (2023), and in the just published ICH Training Materials (Module 4 and 5).
Programm
Regulatory Requirements and the Lifecycle Concept of Analytical Procedures
- FDA validation guidance (2015)
- USP General information chapter <1220>
- Stage 1: Procedure Design and Development
- Stage 2: Procedure Performance Qualification
- Stage 3: Ongoing Procedure Performance Verification - ICH Q14 “Analytical procedure development”
- Draft USP General Information Chapter <1221> “Ongoing Procedure Performance Verification”
Workshop
Sources of data and information on analytical Performance
Sources of data and information on analytical Performance
Evaluation of Procedure Performance
- Risk management: Factors related to analytical procedure criticality & risk-based performance monitoring plans
- Analytical Procedure Performance Metrics (conformity, validity, analytical control parameters)
- Risk-based identification of suitable performance parameters (SST, from sample analysis, control samples)
- Links to Analytical Procedure Control Strategy (ICH Q14, Training Module 4)
- Continued verification of ATP requirements and periodic analytical performance assessment
- Continual improvements
Monitoring and Trend Analysis
- Control charts (Shewhart, range, standard deviation, CUSUM)
- Statistical out-of-control rules
- Pragmatic establishment of trending rules and limits (statistical, empirical)
- Examples
Weitere Informationen
To participate in an on demand training course or webinar, you do not need any software. The recordings are made available via a streaming server. In general, the recording is provided in MP4 format, which any PC (Microsoft Windows, Apple IOS) or tablet can easily Display.
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.
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 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.
Contacts
Questions regarding content:
Dr Markus Funk, +49 (0)6221 84 44 40, funk@concept-heidelberg.de
Questions regarding organisation:
Ms Isabell Helm, +49 (0)6221 84 44 49, helm@concept-heidelberg.de
Questions regarding content:
Dr Markus Funk, +49 (0)6221 84 44 40, funk@concept-heidelberg.de
Questions regarding organisation:
Ms Isabell Helm, +49 (0)6221 84 44 49, helm@concept-heidelberg.de
Recording from 01 December 2025
Duration of the recording: 2 h
Duration of the recording: 2 h
Teilnahmegebühr
| ECA-Member*: | € 590,- |
| Regular Fee*: | € 690,- |
| EU/GMP Inspectorates*: | € 590,- |
| APIC Member Discount*: | € 640,- |
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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