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Mastery in mRNA Manufacturing: Navigating International Regulations & Best Practices
CMC
Pharma & Biotech

Mastery in mRNA Manufacturing: Navigating International Regulations & Best Practices

Date to be announced

Contact us for more info
Price available after dates are announced

TRAINING TIMES

  • TBDVienna
  • TBDLondon
  • TBDNew York
  • TBDLos Angeles
Online Training



LEARNING OBJECTIVES

Learning Objective

Understanding of regulations and pharmacopeial standards relevant to mRNA-based therapeutics

Understanding of regulations and pharmacopeial standards relevant to mRNA-based therapeutics

Learning Objective

Insight into facility design considerations specific to mRNA production, ensuring efficient and compliant manufacturing

Insight into facility design considerations specific to mRNA production, ensuring efficient and compliant manufacturing

Learning Objective

Knowledge of sourcing raw materials and navigating US standards for drug substance and product manufacturing

Knowledge of sourcing raw materials and navigating US standards for drug substance and product manufacturing

Learning Objective

Familiarity with sterile filling, packaging, and transportation protocols essential for maintaining product integrity

Familiarity with sterile filling, packaging, and transportation protocols essential for maintaining product integrity

Learning Objective

Mastery of quality control and testing procedures tailored to meet rigorous regulatory requirements

Mastery of quality control and testing procedures tailored to meet rigorous regulatory requirements

Learning Objective

Adoption of modern process validation strategies aligned with US regulations to ensure product quality and safety

Adoption of modern process validation strategies aligned with US regulations to ensure product quality and safety

Learning Objective

Implementation of effective cross-contamination control measures to maintain manufacturing integrity

Implementation of effective cross-contamination control measures to maintain manufacturing integrity

Learning Objective

Proficiency in supplier qualification methods and material release protocols for mRNA manufacturing

Proficiency in supplier qualification methods and material release protocols for mRNA manufacturing

Learning Objective

Understanding of in-process control strategies and sampling techniques crucial for maintaining process consistency and quality assurance

Understanding of in-process control strategies and sampling techniques crucial for maintaining process consistency and quality assurance

Learning Objective

Awareness of the latest advancements and emerging trends in mRNA therapeutics, empowering attendees to contribute effectively to the rapidly evolving field

Awareness of the latest advancements and emerging trends in mRNA therapeutics, empowering attendees to contribute effectively to the rapidly evolving field



KEY TOPICS

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

TRAINER

Fritz Röder, Merck KGaA, Germany

Fritz Röder, Merck KGaA, Germany

Director Engineering

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. Fritz’s areas of experience includes GMP / QA consulting in various technical questions, technical compliance and inspection preparation (FDA, ANVISA, German RP, Russia etc.). He is a responsible operator of GMP equipment, has expertise in Containment & mRNA and is a profound water treatment expert. On top, Fritz was involved in mRNA projects in Europe concerning design, manufacturing and quality topics of mRNA processes. We are live on webchat!

Learn More →