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Basic Courses
USP Basic Course

USP (UP-stream process)

This course covers the process of cultivating vaccine antigens as part of the Drug Substance (DS) manufacturing process, providing hands-on training in the entire process sequence from initiation (cell and virus seed thawing) to final harvest at predetermined virus amplification levels.

Classification Detailed Courses (Subject Names)
USP Basic Course (Theory, 60 hours) Vaccine Development Process
Vaccine Development QbD
Vaccine Manufacturing Process Utility Management
Facility Engineering in Vaccine Manufacturing
Vaccine USP Process
Vaccine Manufacturing Validation
Vaccine GMP Documentation Management
Quality Assurance (QA) Operations
USP Basic Course (Practical Training, 60 hours) Basic Training in Cleanroom Management for Vaccine Manufacturing
Basic Training in Vaccine USP Process
Basic Training in Vaccine GMP Documentation Management

Basic Course Theoretical Education

Course Name Main Educational Content
Vaccine Development Process Learning fundamental theories about vaccine history, types, development process, and manufacturing processes
  • History and Types of Vaccines
  • Vaccine Development Process
  • Manufacturing Process Concepts and Cases by Vaccine Type
  • Global Regulatory Issues in Pharmaceuticals
Vaccine Development QbD Learning fundamental theories of QbD
  • Overview of QbD, QTPP/CPP/CQA Settings and Overview
  • Design Space Settings and Overview, RA and CS Settings and Overview
Vaccine Manufacturing Process Utility Management Learning fundamental theories about utility roles and management in vaccine manufacturing processes
  • HVAC Systems
  • Clean Utility & Steam Systems & BMS
Facility Engineering in Vaccine Manufacturing Learning fundamental theories about facility engineering roles and tasks in vaccine manufacturing processes
  • Roles of Facility Engineering and Biotech Cleanrooms in Pharmaceutical Manufacturing
  • Safety & Environmental Management, Calibration Management & Preventive Maintenance in Pharmaceutical Manufacturing
Vaccine USP Process Learning basic theories about Upstream Process in vaccine manufacturing
  • GMP Cultivation Process Principles
  • Animal Cell Culture Techniques (Suspension and Adherent Cell Seed Culture, Scale-up) Principles
  • Understanding Virus Infection and Amplification Principles
  • Core Technology Principles in Molecular and Cell Biology
  • Understanding Bioreactors
  • Cell Culture Technology and Perfusion Culture Process Development and Evaluation
Vaccine Manufacturing Validation Learning fundamental validation theories required for vaccine manufacturing processes
  • Validation Overview
  • Qualification Assessment and Cleaning Validation for Pharmaceutical Manufacturing Facilities
  • FDA Process Validation Guideline Interpretation
  • Key Points and Cases of Computerized System Validation
  • Test Method Validation and CSV Process
  • GMP System ICH Q7 API Guide
Vaccine GMP Documentation Management Learning fundamental theories about GMP documentation management in vaccine manufacturing processes
  • Understanding GMP Documentation Management
  • Understanding Standard Operating Procedures
  • Understanding Product Master File Creation and Management
Quality Assurance (QA) Operations Learning fundamental theories about QA roles and tasks in vaccine manufacturing
  • Overview of Quality Systems and Documentation Management Guidelines
  • Case Studies in Deviation Management
  • Understanding CAPA and Case Presentations
  • Deviation Management Based on cGMP Inspection Cases
  • Creation and Management of Product Master Files, Manufacturing Instructions, and Records
  • Understanding Risk Management Theory and Cases, Raw Material Suppliers, and Contract Management

Basic Course Practical Training

Course Name Main Educational Content
Basic Training in Cleanroom Management for Vaccine Manufacturing Acquiring basic practical skills in cleanroom management for vaccine manufacturing facilities
  • Practice in Environmental Monitoring of Airborne Bacteria/Particles/Settling Bacteria/Surface Bacteria
  • Practice in Facility Entry Procedures (Gowning, etc.) and Cleanroom Contamination Control (Alcohol Cleaning, etc.)
  • Practice in Steam Sterilization and Sanitization
Basic Training in Vaccine USP Process Acquiring basic practical skills in the Upstream Process for vaccine manufacturing
  • Practice with Cell Culture Equipment
  • Practice in Using Biosafety Cabinets and CO2 Incubators
  • Practice in Using Automated Cell Viability Analyzers
  • Practice in Virus Infection, Amplification, and Isolation
  • Practice in Using Fluorescence Microscopes and Centrifuges
  • Practice in Using Virus-counting Equipment
Basic Training in Vaccine GMP Documentation Management Acquiring basic practical skills in GMP documentation for vaccine manufacturing processes
  • Practice in GMP Documentation Management, Creating and Managing Standard Operating Procedures
  • Practice in Creating and Managing Product Master Files
DSP Basic Course

DSP (Down-stream process)

This course covers the process of separating, purifying, and formulating vaccine antigens as part of the Drug Substance (DS) manufacturing process. It encompasses a series of process steps performed to ensure productivity and target quality for consistent vaccine bulk production.

Classification Detailed Courses (Subject Names)
DSP Basic Course (Theory, 60 hours) Vaccine Development Process
Vaccine Development QbD
Vaccine Manufacturing Process Utility Management
Facility Engineering in Vaccine Manufacturing
Vaccine DSP Process
Vaccine Formulation Process
Vaccine Drug Product Process
Vaccine GMP Documentation Management
Quality Assurance (QA) Operations
Vaccine Manufacturing Validation
DSP Basic Course (Practical Training, 60 hours) Basic Training in Cleanroom Management for Vaccine Manufacturing
Basic Training in Vaccine DSP Process
Basic Training in Vaccine Formulation Process
Basic Training 8 in Vaccine Drug Product Process
Basic Training in Vaccine GMP Documentation Management

Basic Course Theoretical Education

Course Name Main Educational Content
Vaccine Development Process Learning fundamental theories about vaccine history, types, development process, and manufacturing processes
  • History and Types of Vaccines
  • Vaccine Development Process
  • Manufacturing Process Concepts and Cases by Vaccine Type
  • Global Regulatory Issues in Pharmaceuticals
Vaccine Development QbD Learning fundamental theories about QbD
  • Overview of QbD, QTPP/CPP/CQA Settings and Overview
  • Design Space Settings and Overview, RA and CS Settings and Overview
Vaccine Manufacturing Process Utility Management Learning fundamental theories about utility roles and management in vaccine manufacturing processes
  • HVAC Systems
  • Clean Utility & Steam Systems & BMS
Facility Engineering in Vaccine Manufacturing Learning fundamental theories about facility engineering roles and tasks in vaccine manufacturing processes
  • Roles of Facility Engineering and Biotech Cleanrooms in Pharmaceutical Manufacturing
  • Safety & Environmental Management, Calibration Management & Preventive Maintenance in Pharmaceutical Manufacturing
Vaccine DSP Process Learning fundamental theories about Downstream Process in vaccine manufacturing
  • Understanding GMP Purification Process
  • Understanding Basic Theories and Chromatography Techniques for Protein/Virus/Antigen Purification
  • Global Regulatory Issues in Pharmaceuticals
  • Biological Material Separation Process
  • Column Process Equipment Operation
Vaccine Formulation Process Learning fundamental theories about formulation process management
  • Overview and Application Cases of Formulation Design
  • Overview of Lyophilization Formulation
Vaccine Drug Product Process Learning fundamental theories about drug product process management
  • Introduction to Aseptic Technique and Operations in Aseptic Filling Environment
  • Contamination Control, Environmental Monitoring
  • Vial Preparation and Management Methods, Vial Filling Theory and Practice
  • Drug Product (DP) Evaluation and Troubleshooting
Vaccine GMP Documentation Management Learning fundamental theories about GMP documentation management in vaccine manufacturing processes
  • Understanding GMP Documentation Management
  • Understanding Standard Operating Procedures
  • Understanding Product Master File Creation and Management
Quality Assurance (QA) Operations Learning fundamental theories about QA roles and tasks in vaccine manufacturing
  • Overview of Quality Systems and Documentation Management Guidelines
  • Case Studies in Deviation Management
  • Understanding CAPA and Case Presentations
  • Deviation Management Based on cGMP Inspection Cases
  • Creation and Management of Product Master Files, Manufacturing Instructions, and Records
  • Understanding Risk Management Theory and Cases, Raw Material Suppliers, and Contract Management
Vaccine Manufacturing Validation Learning fundamental validation theories required for vaccine manufacturing processes
  • Validation Overview
  • Qualification Assessment and Cleaning Validation for Pharmaceutical Manufacturing Facilities
  • FDA Process Validation Guideline Interpretation
  • Key Points and Cases of Computerized System Validation
  • Test Method Validation and CSV Process
  • GMP System ICH Q7 API Guide

Basic Course Practical Training

Course Name Main Educational Content
Basic Training in Cleanroom Management for Vaccine Manufacturing Basic training Acquiring basic practical skills in cleanroom management for vaccine manufacturing facilities
  • Practice in Environmental Monitoring of Airborne Bacteria/Particles/Settling Bacteria/Surface Bacteria
  • Practice in Facility Entry Procedures (Gowning, etc.) and Cleanroom Contamination Control (Alcohol Cleaning, etc.)
  • Practice in Steam Sterilization and Sanitization
Basic Training in Vaccine DSP Process Acquiring basic practical skills in Downstream Processes for vaccine manufacturing
  • Practice in Chromatography Techniques for Vaccine Antigen Purification
  • Practice in Using Liquid Chromatography Systems
  • Basic Theory and Practice in Media and Buffer Preparation
  • Practice in Using Training Balances and pH/Conductivity Meters
Basic Training in Vaccine Formulation Process Acquiring basic practical skills in vaccine formulation processes
  • Introduction to Lyophilization Equipment Programs and Essential Practice
Basic Training in Vaccine Drug Product Process Acquiring basic practical skills in vaccine drug product processes
  • Essential Practice in Vial Filling
Basic Training in Vaccine GMP Documentation Management Acquiring basic practical skills in GMP documentation for vaccine manufacturing processes
  • Practice in GMP Documentation Management, Creating and Managing Standard Operating Procedures
  • Practice in Creating and Managing Product Master Files
QC Basic Course

Quality Control (QC)

Analysis to verify the quality of raw materials and products and verification of process abnormalities required for production

Classification Detailed Courses (Subject Names)
DSP Basic Course (Theory, 60 hours) Vaccine Development Process
Vaccine Development QbD
Vaccine Manufacturing Process Utility Management
Facility Engineering in Vaccine Manufacturing
Vaccine GMP Documentation Management
Quality Assurance (QA) Operations
Quality Control (QC) Theory and Basic Practice
Vaccine Manufacturing Validation
DSP Basic Course (Practical Training, 60 hours) Basic Training in Cleanroom Management for Vaccine Manufacturing
Basic Training in Vaccine GMP Documentation Management
Quality Control (QC) Theory and Basic Practice

Basic Course Theoretical Education

Course Name Main Educational Content
Vaccine Development Process Learning fundamental theories about vaccine history, types, development process, and manufacturing processes
  • History and Types of Vaccines
  • Vaccine Development Process
  • Manufacturing Process Concepts and Cases by Vaccine Type
  • Global Regulatory Issues in Pharmaceuticals
Vaccine Development QbD Learning fundamental theories about QbD
  • Overview of QbD, QTPP/CPP/CQA Settings and Overview
  • Design Space Settings and Overview, RA and CS Settings and Overview
Vaccine Manufacturing Process Utility Management Learning fundamental theories about utility roles and management in vaccine manufacturing processes
  • HVAC Systems
  • Clean Utility & Steam Systems & BMS
Facility Engineering in Vaccine Manufacturing Learning fundamental theories about facility engineering roles and tasks in vaccine manufacturing processes
  • Roles of Facility Engineering and Biotech Cleanrooms in Pharmaceutical Manufacturing
  • Safety & Environmental Management, Calibration Management & Preventive Maintenance in Pharmaceutical Manufacturing
Vaccine GMP Documentation Management Learning fundamental theories about GMP documentation management in vaccine manufacturing processes
  • Understanding GMP Documentation Management
  • Understanding Standard Operating Procedures
  • Understanding Product Master File Creation and Management
Quality Assurance (QA) Operations Learning fundamental theories about QA roles and tasks in vaccine manufacturing
  • Overview of Quality Systems and Documentation Management Guidelines
  • Case Studies in Deviation Management
  • Understanding CAPA and Case Presentations
  • Deviation Management Based on cGMP Inspection Cases
  • Creation and Management of Product Master Files, Manufacturing Instructions, and Records
  • Understanding Risk Management Theory and Cases, Raw Material Suppliers, and Contract Management
Quality Control (QC) Theory and Basic Practice Learning fundamental theories about QC roles and tasks in vaccine manufacturing
  • Interpretation of Quality Control Laboratory Inspection Guidelines in WHO, PIC/S, and FDA GMP
  • Understanding and Cases of LIMS (Laboratory Information Management System)
  • Understanding Analytical Instrument Qualification (AIQ), Test Method Validation Requirements and Practice
  • Review of Content Uniformity Testing, Microbiology Laboratory, and Raw Material Quality Control
  • Stability Testing Overview and Implementation Cases
  • Laboratory Operation Management (Including Documentation), Quality Specification Management, and Test Result Analysis Theory
Vaccine Manufacturing Validation Learning fundamental validation theories required for vaccine manufacturing processes
  • Validation Overview
  • Qualification Assessment and Cleaning Validation for Pharmaceutical Manufacturing Facilities
  • FDA Process Validation Guideline Interpretation
  • Key Points and Cases of Computerized System Validation
  • Test Method Validation and CSV Process
  • GMP System ICH Q7 API Guide

Basic Course Practical Training

Course Name Main Educational Content
Basic Training in Cleanroom Management for Vaccine Manufacturing Acquiring basic practical skills in cleanroom management for vaccine manufacturing facilities
  • Practice in Environmental Monitoring of Airborne Bacteria/Particles/Settling Bacteria/Surface Bacteria
  • Practice in Facility Entry Procedures (Gowning, etc.) and Cleanroom Contamination Control (Alcohol Cleaning, etc.)
  • Practice in Steam Sterilization and Sanitization
Basic Training in Vaccine GMP Documentation Management Acquiring basic practical skills in GMP documentation for vaccine manufacturing processes
  • Practice in GMP Documentation Management, Creating and Managing Standard Operating Procedures
  • Practice in Creating and Managing Product Master Files
Quality Control (QC) Theory and Basic Practice Acquiring basic practical skills in QC roles and tasks in vaccine manufacturing
  • Physicochemical QC Basic Practice
  • Practice with UV-spectrophotometer and Osmotic Pressure Measurement Equipment
  • Biological QC Basic Practice
  • Practice with Real-time Gene Detection Equipment and Enzyme Immunoassay Equipment
  • 미Practice in Microbiology Laboratory Management, Raw Material Quality Control
  • Practice in Laboratory Operation Management (including Documentation), Quality Specification Management, and Test Result Analysis