Joint EU/FDA/PDA/ISPE Training on ICH Q10 Pharmaceutical Quality Systems – Presentations (Days 1 & 2)
Joint EU/FDA/PDA/ISPE Training on ICH Q10 Pharmaceutical Quality Systems-Agendas
- ICH Q10 Quality Systems Conference Agenda â US
- ICH Q10 Quality Systems Conference Agenda - Europe
- ICH Q10 Quality Systems Conference Agenda - Japan
Introduction to PQS, Transforming Quality Culture, and the Business Case
- The ICH Q10 Quality System
- Transforming Quality
- Business Case for Pharmaceutical Quality (Cost of Poor Quality)
- Learning From Other Industries
Regulatory Perspectives on Quality Systems
- Pharmaceutical Quality Systems: US Regulatory Perspective
- Pharmaceutical Quality Systems: European Regulatory Perspective
Management Responsibility For Assuring An Effective Quality System
- How Management Should Oversee The System and What PQS Means to Regulators
- Role of Management to Drive Industry Improvement (Case Study)
- Use of Management Review to Drive Quality and Business Improvement (Case Study)
Management Responsibility For The Supply Chain (Contract Operations And Purchased Materials)
- Case Study: Management of Outsourced Activities and Purchased Materials: Addressing the Interfaces (Presentation)
- Management of Supply Chain (APIs and Excipients)
Lifecycle Goals of the PQS
- Designing and Developing Products to Meet Patient Needs
- Q10 Approach to Design
- Technology Transfer
- Case Study: Commercial Manufacturing
Lifecycle Enablers: QRM and KM
- Case Study: Knowledge Management - An Iterative Process
- Case Study: Quality Risk Management - Theory and Practice
- Regulatory Perspective on QRM and Knowledge Management
Maintaining a State of Control throughout the Lifecycle
- State of Control Over the Lifecycle and Process Validation (New and Legacy Products)
- Case Study: Lifecycle Input to Support Continued Product Verification and State of Control of the Commercial Scale Process
- Lifecycle Input to Support Continued Product Verification and State of Control of the Commercial Scale Process- Case Studies
The Process Performance and Product Quality Monitoring System
- Product Quality Indicators
- Product Quality Management
- Case Study: Use of Statistical Process Control Approaches to Detect Process Drift; Using Process Capability Measurement