Summary
This 3-day online training is a deep dive into the world of messenger ribonucleic acid (mRNA). You will obtain detailed information about the manufacturing and quality characteristics and intensify your know-how about the process of scaling up and the transfer of know-how from the development stage to the market manufacturing stage.
Learning Objectives
- Understand the regulatory landscape
- Overview over GMP and quality requirements for the manufacture of mRNA medicinal products
- Learn about development and the basic requirements for manufacturing
- How to manage facilities, utilities and equipment?
- Modern cross contamination prevention concepts
- Modern process validation concepts
- How to implement effective process changes?
- Implementation of analytical methods
- How to implement a good In-Process Control concept?
- Tech transfer from the development to the market manufacturing department
Key Topics
- Regulatory framework
- Quality & GMP requirements
- Manufacturing of the drug substance
- Sterile filling
- Process validation
- Managing process changes
- Analytical methods
- Release specification vs IPC requirements
Who should attend?
Quality Assurance and Quality Control Manager, Regulatory Affairs Manager, Process Validation Specialist, Manufacturing Management, Process Development, Research and Development
Our online training experience includes
- Our client zone – a single source for all training materials as well as pre and post-training communication
- Live interactive format via the Zoom platform
- Direct interaction with the trainer
- Q&As, case studies, polls
- Revisit recorded sessions for 7 days
- Training in digital format
- Digital and LinkedIn certificates
Trainers
Dr. Felix Tobias Kern is the Associate Director - Head of Compliance Launch and Technology Center at the Merck KGaA in Darmstadt (Germany). He studied pharmacy in Mainz (Germany) and graduated at the Ludwig-Maximilians-University in Munich (Germany). He is an expert pharmacist for pharmaceutical analytics and pharmaceutical technology.
Manufacturing of mRNA-Based Therapeutics
Download the full training agenda to reveal complete session details, training takeaways, case studies, daily schedule, special features and full trainer bio.
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