Programs

Course Content: 

• a)    The road to a Pharmaceutical Quality System Principles of process validation
• b)    Introduction to the PQS

1. General requirements
2. Documentation

• c)    Main elements of a PQS

1. Management responsibility
2. Resource management
3. Manufacturing operations
4. Evaluation activities:-

• Deviation investigation 
• Product Quality Review (Annual Product Review)
• Change management
• Corrective and Preventive Actions (CAPA)
• Data analysis

• • d)    ICH Q10
  • e)     Structure of a PQS quality manual – example
  • f)     Correlation between GMP requirements (WHO) and ISO 9001