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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⢠Introduction to RNA Therapeutics: Understanding the basics of RNA therapeutics, including RNA mechanisms, types of RNA, and their potential as therapeutic agents.
⢠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.
⢠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.
⢠Analytical Methods in RNA Therapeutics: Examining the analytical techniques used to characterize RNA therapeutics, including electrophoresis, sequencing, and stability assays.
⢠Regulatory Considerations for RNA Therapeutics: Understanding the regulatory landscape for RNA therapeutics, including regulatory requirements, guidelines, and approval processes.
⢠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).
⢠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.
⢠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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