USP Advanced Course

Advanced Course Theory/Practical Training

Course Name Main Educational Content
USP Process Advanced Learning theory and practical skills in the Upstream Process for vaccine manufacturing
  • Cell Bank/Virus Bank Manufacturing
  • Culture Characteristic Analysis Theory and Practice
  • Animal Cell Culture System Operation (Wave, SUB) Theory and Practice
  • Understanding Animal Cell Culture Systems and Scale-up Theory and Practice
  • Culture Medium Recovery Process Theory and Practice
  • Culture Metabolite and Vaccine Drug Substance Analysis Theory and Practice
  • Manufacturing Record Creation Theory and Practice
Advanced Vaccine Manufacturing Monitoring Theory and Practice in Vaccine Manufacturing Monitoring
  • Theory and Practice in Vaccine Manufacturing Facility Entry and Gowning Management
  • Theory and Practice in Facility Environmental Monitoring
DSP Advanced Course

Advanced Course Theory/Practical Training

Course Name Main Educational Content
DSP Process Advanced Learning theory and practical skills in Downstream Processes for vaccine manufacturing
  • Buffer Preparation Theory and Practice
  • Chromatography Column Packing Theory and Practice
  • Chromatography System Operation Theory and Practice
  • Virus Inactivation Theory and Practice
  • Ultrafiltration/Diafiltration (UF/DF) Theory and Practice
  • Filter Integrity Test Theory and Practice
  • Manufacturing Record Creation Theory and Practice
Formulation/Drug Product Process Advanced Learning theory and practical skills in drug product process for vaccine manufacturing
  • Theory and Practice in Aseptic Filling Environment Operations
  • AAutoclave Operation Theory and Practice
  • Buffer & Final Bulk Preparation Theory and Practice
  • Filling/Capping, Lyophilizer Operation Theory and Practice
Advanced Vaccine Manufacturing Monitoring Theory and Practice in Vaccine Manufacturing Monitoring
  • Theory and Practice in Vaccine Manufacturing Facility Entry and Gowning Management
  • Theory and Practice in Facility Environmental Monitoring
QC Advanced Course

Advanced Course Theory/Practical Training

Course Name Main Educational Content
Quality Control (QA/QC) Advanced Learning theory and practical skills in QA/QC for vaccine quality (QA)
  • Overall GMP System, QbD, QA Theory and Practice
  • Theory and Practice in Creating GMP Documents, including SOPs, Test Specifications, Manufacturing Records
  • Theory and Practice in Change Control and Deviation Documentation
  • Theory and Practice in Qualification Assessment/Validation Documentation
  • Data integrity
(QC)
  • Process Water Testing and Environmental Monitoring Theory and Practice
  • Purity and Content Testing (ELISA, q-PCR, Plaque Assay) Theory and Practice
  • HPLC, GC Analysis Theory and Practice
  • Stability Testing Theory and Practice
  • Release Testing and Quality Characteristic Analysis Theory and Practice
Advanced Vaccine Manufacturing Monitoring Theory and Practice in Vaccine Manufacturing Monitoring
  • Theory and Practice in Vaccine Manufacturing Facility Entry and Gowning Management
  • Theory and Practice in Facility Environmental Monitoring