Certificate in RNA Therapeutics: Quality by Design
-- ViewingNowThe Certificate in RNA Therapeutics: Quality by Design is a comprehensive course that addresses the growing demand for RNA therapeutics in the pharmaceutical industry. This program emphasizes the importance of quality by design (QbD) principles in RNA therapeutic development, a critical area as we strive to create safer, more effective treatments.
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โข Introduction to RNA Therapeutics: Understanding the basics of RNA therapeutics, including RNA mechanisms, types of RNA, and their potential as therapeutic agents.
โข Quality by Design (QbD) Principles: An overview of QbD concepts, including quality target product profile (QTPP), critical quality attributes (CQAs), critical process parameters (CPPs), and design space.
โข RNA Therapeutics Design and Development: Exploring the design and development process for RNA therapeutics, including target identification, sequence design, in vitro and in vivo validation, and preclinical studies.
โข Analytical Methods in RNA Therapeutics: Examining the analytical techniques used to characterize RNA therapeutics, including electrophoresis, sequencing, and stability assays.
โข Regulatory Considerations for RNA Therapeutics: Understanding the regulatory landscape for RNA therapeutics, including regulatory requirements, guidelines, and approval processes.
โข Quality Risk Management in RNA Therapeutics: Implementing quality risk management strategies in the development and manufacturing of RNA therapeutics, including failure modes and effects analysis (FMEA), and Hazard Analysis and Critical Control Points (HACCP).
โข Manufacturing and Scale-Up of RNA Therapeutics: Investigating the manufacturing processes for RNA therapeutics, including synthesis, purification, and formulation, as well as scale-up considerations.
โข Quality Control and Assurance in RNA Therapeutics: Establishing quality control and assurance systems to ensure product quality, consistency, and compliance with regulatory requirements.
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