Review of ICH as an organisation:
• Objectives of ICH
• Regulatory standing of the organization
Overview of their methodology:
Review of the Quality Guidelines
Q1 Stability Testing
Q2 Analytical Methods Validation
Q4 Regulatory Acceptance of Analytical Procedures and Acceptance Criteria
Q5 Viral Safety Evaluation – Biotech Products
Q6 Specifications: Test Procedures and Acceptance Criteria
Q7 GMPs for Active Pharmaceutical Ingredients
Q8 Pharmaceutical Development
Q9 Risk Management
Q10 Pharmaceutical Quality System
Take home material: Participants will take home a binder with complete, current copies of each of the ten quality guidelines, for their future reference.
This one day seminar will review the place of ICH as an organisation in the worldwide regulatory framework. All 9 current guides will be reviewed and discussed as well as the draft Q10 Pharmaceutical Quality System Guide.