Dr Heiko Brunner
Hamburg
Referent:innen
Dr Gerd Jilge
Formerly Boehringer Ingelheim
Zielgruppe
This Live Online Training is designed for participants who wish to expand their knowledge of SST and troubleshooting of HPLC methods. It is particularly aimed at:
- Heads of Quality Control
- Qualified Persons (QP)
- Laboratory Managers
- and all laboratory staff in pharmaceutical quality control and analytical development.
It is also relevant for professionals from control departments of active pharmaceutical ingredient (API) and excipient manufacturers, as well as contract laboratories. Furthermore, this Live Online Training is of interest to employees and managers in quality assurance.
Zielsetzung
This Live Online Training provides a comprehensive insight into the requirements of SST criteria, including their acceptance limits. The event combines theoretical concepts and case studies with practical exercises to equip participants with a thorough understanding of HPLC method evaluation and troubleshooting.
Background
The SST is an essential part of any GMP analysis, particularly when applying chromatographic methods. It ensures the proper functioning of both the analytical system and the corresponding analytical procedure, including sample preparation.
Before establishing new HPLC methods in one's own laboratory, a thorough review and evaluation are necessary. Potential sources for new methods include external laboratories (as part of method transfer), literature descriptions, pharmacopoeial monographs, or inhouse developments. A detailed analysis of potential weaknesses can help prevent later issues, including variation applications in regulatory approvals. If difficulties arise when applying a new method, troubleshooting can often be time-consuming and costly.
Before establishing new HPLC methods in one's own laboratory, a thorough review and evaluation are necessary. Potential sources for new methods include external laboratories (as part of method transfer), literature descriptions, pharmacopoeial monographs, or inhouse developments. A detailed analysis of potential weaknesses can help prevent later issues, including variation applications in regulatory approvals. If difficulties arise when applying a new method, troubleshooting can often be time-consuming and costly.
Programm
System Suitability Test (SST)
- Importance of SST – Why is the system suitability test so important?
- Regulatory requirements
- Current changes in the pharmacopoeial SST chapters
- SST parameters and their acceptance criteria
- How to obtain the optimal SST (development of SST)?
- Dos and Don'ts of SST
- How can SST contribute to the "Analytical Life Cycle"?
- Why is SST not sufficient for the qualification of analytical systems?
- Examples of System Suitability Tests for other chromatographic and non-chromatographic analytical Methods
- Is an SOP required for SST?
Evaluation and Troubleshooting of HPLC Methods
- Common issues and their causes
- Evaluation criteria for HPLC Methods
- Choosing the right method Parameters
- Diagnostic tools, checklists, and performance Monitoring
- Assessment of chromatograms
- Approaches to error correction and solution strategies
Interactive Learning Components
- Quiz – deepening Knowledge
- Case studies – practical examples on troubleshooting
- Interactive workshop – group work: troubleshooting an HPLC method
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 04 November 2025
Duration of the recording: 4 h 55 min
Duration of the recording: 4 h 55 min
Teilnahmegebühr
| ECA-Member*: | € 1090,- |
| Regular Fee*: | € 1290,- |
| EU/GMP Inspectorates*: | € 645,- |
| APIC Member Discount*: | € 1190,- |
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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