Practical approaches for identification and control
Thursday, 19 November 2026 10.00 - 17.15 h
Course No. 22821
Speakers
Osama Chahrour
Astra Zeneca
• EMA Guideline for Development and Manufacture of Synthetic Peptides • Peptide Related Impurities: Root Causes and Case Studies • Peptide Synthesis: Process Understanding and Case Studies
Target Group
This Live Online Training is prepared for personnel from Quality Control, Quality Assurance, development and production who want to gain a better understanding of the requested regulatory requirements for Synthetic Peptides, as well as having an efficient process and peptide related impurities understanding.
Objectives
This Live Online Training explains specific aspects regarding Synthetic Peptides and their impurities. How to use, create and implement an Impurities Risk Assessment will be shown and the evaluation of the risks will be discussed. The requirements and definitions of the EMA “Guideline on the Development and Manufacture of Synthetic Peptides” will be provided and analytical techniques and control strategies related to the guidance document will be explained.
Programme
Foundations of Peptide CMC: Scope, Terminology, Regulatory Context
Peptide regulatory definition and differences between regulatory jurisdictions
Applicability of ICH guidelines
Peptide Synthesis: Process Understanding and Case Studies
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: Root Causes and Case Studies
Peptide-related impurities including different types and the related control strategy
Related impurities risk assessment and number of case studies
EMA Guideline for Development and Manufacture of Synthetic Peptides
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.
Testimonials
