Vaccine Safety Basics

  1. Surveillance
  2. Vaccine safety institutions and mechanisms
  3. Communication

Validation

  1. General overview on qualification and validation
  2. Qualification of HVAC and water systems
  3. Cleaning validation
  4. Analytical method validation
  5. Computerized system validation
  6. Qualification of systems and equipment
  7. Non sterile product process validation

Water for Pharmaceutical Use

  1. Introduction and treatment
  2. Water purification and engineering
  3. Inspection of water purification systems
  4. Commissioning, Qualification and validation

Air Handling Systems (HVAC)

  1. Introduction and overview
  2. Introduction and overview (2)
  3. HVAC systems and components
  4. Commissioning, qualification and maintenance

Clinical studies management

  1. Overview on vaccine clinical development
  2. Clinical development plan
  3. How to design a clinical trial : general principles
  4. Writing the clinical study protocol
  5. Writing a clinical development plan
  6. Statistical Analysis Plan and Clinical Study Report
  7. ICH-GCP-Good Clinical Practice