Professional Certificate in Quality Control in Biopharma
-- ViewingNowThe Professional Certificate in Quality Control in Biopharma is a comprehensive course designed to meet the growing industry demand for skilled professionals. This certificate course emphasizes the importance of quality control in biopharma, encompassing the regulations, standards, and best practices necessary to ensure product safety and efficacy.
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โข Introduction to Quality Control in Biopharma: Regulations, Compliance, and Quality Systems
โข Fundamentals of Biopharma Manufacturing: Cell Culture, Fermentation, and Recovery Operations
โข Biopharma Testing Methods: Microbiological, Chemical, and Biochemical Assays
โข Quality Control Laboratory Operations: Equipment, Instruments, and Validation
โข Data Management and Statistics: Design of Experiments, Hypothesis Testing, and Data Integrity
โข Quality Risk Management: Hazard Analysis, Critical Control Points (HACCP), and Failure Mode Effects Analysis (FMEA)
โข Change Control and Deviation Management: Change Request, Impact Assessment, and Root Cause Analysis
โข Regulatory Affairs: FDA, EMA, and ICH Guidelines, and Quality Agreements
โข Quality Control in Upstream and Downstream Processes: Product and Process Validation, and Process Analytical Technology (PAT)
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