Target Group
- Laboratory managers, supervisors and analysts,
- Quality control managers,Heads of quality control,
- Qualified Persons (QPs),
- Analytical scientists,
- Senior laboratory staff,
- Responsible authorities,
- Service providers (contract research organisations and contract manufacturers).
Objectives
- providing a structured approach to handling Out of Specification (OOS) and Out of Trend (OOT) results,
- explaining key regulatory and guidance expectations and how they translate into practical lab procedures,
- applying trend analysis tools and statistical rules to evaluate OOT signals – incl. understanding common pitfalls and misinterpretations – through an interactive Excel-based exercise.
Programme
Microbiological Insights into the Analytical Life Cycle of mRNA-based Therapeutics
Dr Thomas Meindl, Thermo Labor LS
Addressing mRNA vaccines in the European Pharmacopoeia - New Ph. Eur. Texts
Dr Thuy Bourgeois, EDQM - Council of Europe
Building a Robust CMC Framework for mRNA Therapeutics: From Raw Materials to Drug Product Release
Dr Mohamad Toutounji, Molgenium
CMC Strategies for saRNA Therapeutics: Optimizing T7 Polymerase, IVT Processes, and Quality Control to Accelerate Clinical Translation
Mengqian Mao, Novoprotein
Setting up Specifications: Considerations and Approaches
Dr Jan M. Falcke, BioNTech
Homing In on Fit-for-Purpose Biophysical Techniques for mRNA and LNP Characterization
Dr Natalia Markova, Freelance Consultant
Endotoxin Detection via a Low-Cost Electrochemical Test Strip and Reader Approach
Prof Dr Damion Corrigan, Aureum DX
Case Studies for mRNA Therapeutics – Developing Reliable and Robust Potency Methods
Dr Frances Reichert, Eurofins
mRNA Products as ATMP and as Vaccine - Same Technology but Different Requirements
Dr Sabina Hauck, dequra pharma consult hauck
Costs
| Regular Fee*: | € 690,- |
(All prices excl. VAT). Important notes on sales tax.
not available
Not available
Please contact us:
Tel.: +49 6221 8444-0
E-Mail: info@gmp-compliance.org
Testimonials
