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Mastery in mRNA Manufacturing (US)
Mastery in mRNA Manufacturing (US)

Course Description

Discover the cutting-edge world of mRNA-based therapeutics for international markets. Led by industry leaders, this nine-session course is tailored to meet the unique needs and regulatory requirements of the US pharmaceutical landscape.

Explore EU and FDA guidelines, pharmacopeia standards, and facility design specifics crucial for mRNA production worldwide. Gain practical insights into navigating complex regulatory frameworks and optimizing manufacturing processes for success in the US and international market. Specifically, EU guidelines are complex regarding mRNA technology, and they are used also worldwide.

From sterile filling to packaging and transportation, learn the meticulous standards required to ensure product integrity and regulatory compliance. Dive deep into quality control protocols, testing standards, and modern process validation strategies.

Join us to uncover crucial insights on cross-contamination control, supplier qualification, and in-process control strategies, essential for staying ahead in the dynamic world of mRNA manufacturing. Elevate your expertise and accelerate your success in the American pharmaceutical industry with this comprehensive course.

  • Regulatory Frameworks: FDA and EU guidelines as well as pharmacopeia standards
  • Facility Design: Layout considerations for mRNA production
  • Manufacturing Processes: Sourcing raw materials and ensuring compliance with international standards
  • Sterile Filling and Packaging: Protocols for maintaining product integrity
  • Quality Control and Testing: Rigorous standards and analytical methods
  • Process Validation Strategies: Modern approaches
  • Cross-Contamination Control: Strategies to prevent contamination
  • Supplier Qualification: Modern methods for qualifying suppliers
  • In-Process Control Strategies: Implementing controls and sampling strategies
  • Understanding of regulations and pharmacopeial standards relevant to mRNA-based therapeutics
  • Insight into facility design considerations specific to mRNA production, ensuring efficient and compliant manufacturing
  • Knowledge of sourcing raw materials and navigating US standards for drug substance and product manufacturing
  • Familiarity with sterile filling, packaging, and transportation protocols essential for maintaining product integrity
  • Mastery of quality control and testing procedures tailored to meet rigorous regulatory requirements
  • Adoption of modern process validation strategies aligned with US regulations to ensure product quality and safety
  • Implementation of effective cross-contamination control measures to maintain manufacturing integrity
  • Proficiency in supplier qualification methods and material release protocols for mRNA manufacturing
  • Understanding of in-process control strategies and sampling techniques crucial for maintaining process consistency and quality assurance
  • Awareness of the latest advancements and emerging trends in mRNA therapeutics, empowering attendees to contribute effectively to the rapidly evolving field  

Mastery in mRNA Manufacturing (US)

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

Discover the cutting-edge world of mRNA-based therapeutics for international markets. Led by industry leaders, this nine-session course is tailored to meet the unique needs and regulatory requirements of the US pharmaceutical landscape.

Explore EU and FDA guidelines, pharmacopeia standards, and facility design specifics crucial for mRNA production worldwide. Gain practical insights into navigating complex regulatory frameworks and optimizing manufacturing processes for success in the US and international market. Specifically, EU guidelines are complex regarding mRNA technology, and they are used also worldwide.

From sterile filling to packaging and transportation, learn the meticulous standards required to ensure product integrity and regulatory compliance. Dive deep into quality control protocols, testing standards, and modern process validation strategies.

Join us to uncover crucial insights on cross-contamination control, supplier qualification, and in-process control strategies, essential for staying ahead in the dynamic world of mRNA manufacturing. Elevate your expertise and accelerate your success in the American pharmaceutical industry with this comprehensive course.

  • Regulatory Frameworks: FDA and EU guidelines as well as pharmacopeia standards
  • Facility Design: Layout considerations for mRNA production
  • Manufacturing Processes: Sourcing raw materials and ensuring compliance with international standards
  • Sterile Filling and Packaging: Protocols for maintaining product integrity
  • Quality Control and Testing: Rigorous standards and analytical methods
  • Process Validation Strategies: Modern approaches
  • Cross-Contamination Control: Strategies to prevent contamination
  • Supplier Qualification: Modern methods for qualifying suppliers
  • In-Process Control Strategies: Implementing controls and sampling strategies
  • Understanding of regulations and pharmacopeial standards relevant to mRNA-based therapeutics
  • Insight into facility design considerations specific to mRNA production, ensuring efficient and compliant manufacturing
  • Knowledge of sourcing raw materials and navigating US standards for drug substance and product manufacturing
  • Familiarity with sterile filling, packaging, and transportation protocols essential for maintaining product integrity
  • Mastery of quality control and testing procedures tailored to meet rigorous regulatory requirements
  • Adoption of modern process validation strategies aligned with US regulations to ensure product quality and safety
  • Implementation of effective cross-contamination control measures to maintain manufacturing integrity
  • Proficiency in supplier qualification methods and material release protocols for mRNA manufacturing
  • Understanding of in-process control strategies and sampling techniques crucial for maintaining process consistency and quality assurance
  • Awareness of the latest advancements and emerging trends in mRNA therapeutics, empowering attendees to contribute effectively to the rapidly evolving field  

"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

Mastery in mRNA Manufacturing (US)

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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