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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