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Manufacturing of mRNA-Based Therapeutics
Manufacturing of mRNA-Based Therapeutics

Course Description

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.
  • Regulatory framework
  • Quality & GMP requirements
  • Manufacturing of the drug substance
  • Sterile filling
  • Process validation
  • Managing process changes
  • Analytical methods
  • Release specification vs IPC requirements
  • 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

Manufacturing of mRNA-Based Therapeutics

15 - 17 October 2024, Live Online Training
Regular price €1.850,00
Unit price
per 
Dr. Felix Kern

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.

Fritz Röder

Fritz Röder is Director Engineering at Merck KGaA in Germany and is a recognized expert in the pharmaceutical industry. He has large experience in pharmaceutical media supply, GMP environments and the processing of solid, semisolid and liquid (sterile) dosage forms.

START TIMES

11:00 AM New York time

8:00 AM Los Angeles time

4:00 PM London time

5:00 PM Vienna time

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Course Description

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.
  • Regulatory framework
  • Quality & GMP requirements
  • Manufacturing of the drug substance
  • Sterile filling
  • Process validation
  • Managing process changes
  • Analytical methods
  • Release specification vs IPC requirements
  • 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

"Trainer is very competent and has the complete knowledge of the matter."

– Senior Process Expert, B. Braun

"It is not at all frequent to find this grade of preparation and reaction to specific cases such as the ones presented. I'm enthusiastic! Thanks really."

– Tech Transfer Lead, Novartis

"Thank you for sharing all the links and informative material. Very professional organization and execution."

– Manufacturing Manager, Thermo Fisher Scientific

"The trainer was very knowledgeable about the topics and was able to answer all questions."

– Drug Product Subject Matter Expert, Pfizer

"Excellent work of the lecturer, good materials, clear explanations."

– Clinical Pharmacologist, Boehringer Ingelheim

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.

Medical-Devices-Certificate-Course

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