Advanced Certificate in RNA Therapeutics: Quality Management
-- ViewingNowThe Advanced Certificate in RNA Therapeutics: Quality Management is a comprehensive course designed to equip learners with the essential skills necessary for success in the rapidly growing field of RNA therapeutics. This certificate course focuses on quality management, an area of critical importance for the development and production of safe and effective RNA-based drugs.
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Here are the essential units for an Advanced Certificate in RNA Therapeutics: Quality Management:
● Quality Management Systems (QMS) for RNA Therapeutics: An introduction to the fundamental principles and requirements of a QMS in the development and production of RNA therapeutics, including regulatory requirements and best practices.
● Regulation of RNA Therapeutics: An overview of the regulatory landscape for RNA therapeutics, including current regulations and guidelines in major markets, such as the FDA and EMA, and the role of quality management in regulatory compliance.
● Design Control for RNA Therapeutics: A deep dive into the design control process for RNA therapeutics, including design input, output, and review, and the role of quality management in ensuring a robust and efficient design process.
● Risk Management for RNA Therapeutics: A comprehensive examination of risk management in RNA therapeutics, including the identification, assessment, and mitigation of risks throughout the product lifecycle, and the role of quality management in managing risk.
● Change Management for RNA Therapeutics: A review of the change management process for RNA therapeutics, including the identification, assessment, and implementation of changes, and the role of quality management in ensuring a controlled and efficient change process.
● Validation and Qualification for RNA Therapeutics: An exploration of the validation and qualification processes for RNA therapeutics, including process validation, equipment qualification, and computer system validation, and the role of quality management in ensuring validated and qualified processes and systems.
● Quality Control for RNA Therapeutics: A detailed examination of quality control in RNA therapeutics, including testing and release, and the role of quality management in ensuring a high level of quality control.
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