Vaccine Safety Basics
- Surveillance
- Vaccine safety institutions and mechanisms
- Communication
Validation
- General overview on qualification and validation
- Qualification of HVAC and water systems
- Cleaning validation
- Analytical method validation
- Computerized system validation
- Qualification of systems and equipment
- Non sterile product process validation
Water for Pharmaceutical Use
- Introduction and treatment
- Water purification and engineering
- Inspection of water purification systems
- Commissioning, Qualification and validation
Air Handling Systems (HVAC)
- Introduction and overview
- Introduction and overview (2)
- HVAC systems and components
- Commissioning, qualification and maintenance
Clinical studies management
- Overview on vaccine clinical development
- Clinical development plan
- How to design a clinical trial : general principles
- Writing the clinical study protocol
- Writing a clinical development plan
- Statistical Analysis Plan and Clinical Study Report
- ICH-GCP-Good Clinical Practice