Dr Heiko Brunner
Hamburg
Referent:innen
Dr Gerd Jilge
Formerly Boehringer Ingelheim
All times mentioned are CET.
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.
Hintergrund
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.
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.
Date & Technical Requirements
Date
Tuesday, 04 November 2025
09.00 – 17.00 h CET
Technical Requirements
We use WebEx for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Tuesday, 04 November 2025
09.00 – 17.00 h CET
Technical Requirements
We use WebEx for our live online training courses and webinars. At www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our trainings and you can check if your system meets the necessary requirements to participate. If the installation of browser extensions is not possible due to your rights in the IT system, please contact your IT department. WebEx is a standard nowadays and the necessary installation is fast and easy.
Programm
Gesamtes Programm als PDF herunterladen
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
| 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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Seminarprogramm als PDF
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