Biotechnology
BIOT 6320: Quality Management Systems and Validation
Lecture - 3 credits
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- Emphasizes quality management systems (QMS) and validation as it relates to the production and processes related to pharmaceuticals, including biopharmaceuticals.
- Discusses the implementation of a QMS plan, to include document processes, procedures, metrics, reporting, and responsibilities, aligned with pharmaceutical and biotechnology companies’ business objectives.
- Emphasizes implementation, signaling problems (continual improvement), transparency, validation, and team cooperation/dynamics.
- Specifically discusses the International Council on Harmonisation (ICH) Q10 guidelines.
- Topics related to QMS may include objectives, manual, organization structural responsibilities, data management, processes, product quality, continuous improvement plans, quality instruments, and document control.
Emphasizes quality management systems (QMS) and validation as it relates to the production and processes related to pharmaceuticals, including biopharmaceuticals. Show more.