• Peptide Related Impurities: Root Causes and Case Studies
• Peptide Synthesis: Process Understanding and Case Studies
Target Group
Objectives
Programme
- Peptide regulatory definition and differences between regulatory jurisdictions
- Applicability of ICH guidelines
- Peptide synthesis methodologies for example Solid Phase Peptide Synthesis (SPPS) vs. liquid phase
- SPPS process stages e.g. RSM selection, resin/linker choices and roles, purification, etc.
- Coupling/cleavage chemistry and critical process parameters
- Peptide-related impurities including different types and the related control strategy
- Related impurities risk assessment and number of case studies
- Pharmaceutical industry feedback and reflections
- Peptide submission discussion considering the guidance
- Analytical techniques and control strategy aspects related to the guidance
Further Information
Technical Requirements
We use Webex for our live online training courses and webinars. At https://www.gmp-compliance.org/training/online-training-technical-information you will find all the information you need to participate in our events 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.
Fees (per delegate plus VAT)
ECA Members € 990
APIC Members € 1,090
Non-ECA Members € 1,190
EU GMP Inspectorates € 595
The fee is payable in advance after receipt of invoice.
Presentations/Certificate
The presentations will be made available to you prior to the Live Online Training as PDF files. After the event, you will automatically receive your certificate of participation.
Conference language
The official conference language will be English.
Contacts
Questions regarding content:
Ms Anne Günster (Operations Director) +49 62 21 84 44-50, guenster@concept-heidelberg.de
Questions regarding organisation:
Mr Maximillian Bauer (Organisation Manager) +49 62 21 84 44-25, bauer@concept-heidelberg.de
Date & Time
Costs
| ECA-Member*: | € 990,- |
| Regular Fee*: | € 1190,- |
| EU/GMP Inspectorates*: | € 595,- |
| APIC Member Discount*: | € 1090,- |
(All prices excl. VAT). Important notes on sales tax.
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Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org
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