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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⢠Introduction to Quality Control in Biopharma: Regulations, Compliance, and Quality Systems
⢠Fundamentals of Biopharma Manufacturing: Cell Culture, Fermentation, and Recovery Operations
⢠Biopharma Testing Methods: Microbiological, Chemical, and Biochemical Assays
⢠Quality Control Laboratory Operations: Equipment, Instruments, and Validation
⢠Data Management and Statistics: Design of Experiments, Hypothesis Testing, and Data Integrity
⢠Quality Risk Management: Hazard Analysis, Critical Control Points (HACCP), and Failure Mode Effects Analysis (FMEA)
⢠Change Control and Deviation Management: Change Request, Impact Assessment, and Root Cause Analysis
⢠Regulatory Affairs: FDA, EMA, and ICH Guidelines, and Quality Agreements
⢠Quality Control in Upstream and Downstream Processes: Product and Process Validation, and Process Analytical Technology (PAT)
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