Bio GMP Technology Training Course

Bio GMP Tech Course

Bio GMP Technology Personnel Training Course

Week	Subject	(9 weeks) Detailed Education Content	Remarks
Week 1	Basic Training	Orientation of the educational program, introduction to the institution and facilities Education on the safety management of biopharmaceuticals	Practical Education
Week 1	Advanced Bio GMP Education	Understanding GMP, validation, and qualification Writing validation protocols Practical training in writing validation reports	Quality Assurance (QA)
Week 2	Bio-Pharmaceutical Processes (Microbial-based)	Understanding the development process of microbial culture-based biopharmaceuticals Practical training in microbial culture / laboratory safety education Practical training in biopharmaceutical analysis / SDS-PAGE, etc.	Research and Development
Week 3	Bio-Pharmaceutical Processes (Cell-based)	Vaccines, immunotherapy, cell therapy, etc. based on cell culture Advanced biopharmaceutical development processes Practical training in medium preparation for cell culture, cell culture practices
Week 4	GMP Quality Control Test Analysis for Vaccines and Other Biopharmaceuticals	General understanding of GMP quality control / QC operations Management and practical training in aseptic laboratories Practical training in badge performance tests Practical training in mycoplasma detection tests Understanding and practical training in animal cell culture tests Practical training in endotoxin tests Theory and practical training in HPLC test analysis Practical training in environmental testing (particulate matter, airborne bacteria) General injection tests	Quality Control(QC)
Week 5	Cell Culture Vaccine Production Processes	Understanding GMP lines for cell culture-based pharmaceutical manufacturing Practical training in the production of cell culture vaccines and gene cell therapy products Theory and practical training in the purification of biopharmaceuticals based on cell culture GMP manufacturing hygiene management for cell culture	Production
Week 6	Microbial Culture Pharmaceutical Production Processes	Understanding GMP lines for microbial culture-based pharmaceutical manufacturing Practical training in the production processes of plasmid DNA through microbial culture Processes of microbial fermentation and separation and purification of pharmaceutical raw materials Theory and management of aseptic preparation Filter integrity test Freeze-drying of finished pharmaceutical products	Production
Week 7	Maintenance of GMP Manufacturing Facilities Utilities	Understanding the layout of GMP manufacturing facilities Practical training in utilities Maintenance of water treatment devices for purified water and water for injection Maintenance, etc. of air purification and air conditioning systems	Production
Week 8	Raw Material Storage Management	Establishing raw material test standards and sample collection regulations Management of reagents/solutions Management of raw material specifications Use and management of pipettes	Quality Control (QC)
Week 9	GMP Operational Management	Quality control systems for biopharmaceuticals GMP document management, reporting, and handling of deviations	Quality Control (QC)