Joint EU/FDA/PDA/ISPE Training on ICH Q10 Pharmaceutical Quality Systems-Agendas

• ICH Q10 Quality Systems Conference Agenda – US (PDF - 92KB)
  October 4-6, 2011
• ICH Q10 Quality Systems Conference Agenda - Europe
  November 14-16, 2011
• ICH Q10 Quality Systems Conference Agenda - Japan (PDF - 134KB)
  November 5-6, 2012

Introduction to PQS, Transforming Quality Culture, and the Business Case

Day 1 (Plenary 1 and 2: Pharmaceutical Quality Systems)

• The ICH Q10 Quality System (PDF - 422KB)
• Transforming Quality (PDF - 482KB)
• Business Case for Pharmaceutical Quality (Cost of Poor Quality) (PDF - 1MB)
• Learning From Other Industries (PDF - 437KB)

Regulatory Perspectives on Quality Systems

Day 1 (Plenary 1 and 2: Pharmaceutical Quality Systems)

• Pharmaceutical Quality Systems: US Regulatory Perspective (PDF - 396KB)
• Pharmaceutical Quality Systems: European Regulatory Perspective (PDF - 291KB)

Management Responsibility For Assuring An Effective Quality System

Day 1 (Plenary 3 and 4: Management Responsibility)

• How Management Should Oversee The System and What PQS Means to Regulators (PDF - 254KB)
• Role of Management to Drive Industry Improvement (Case Study) (PDF - 180KB)
• Use of Management Review to Drive Quality and Business Improvement (Case Study) (PDF - 425KB)

Management Responsibility For The Supply Chain (Contract Operations And Purchased Materials)

Day 1 (Plenary 3 and 4: Management Responsibility) (Cont'd)

• Case Study: Management of Outsourced Activities and Purchased Materials: Addressing the Interfaces (Presentation) (PPTX - 283KB)
• Management of Supply Chain (APIs and Excipients) (PDF - 487KB)

Lifecycle Goals of the PQS

Day 2 (Plenary 5: Lifecycle Goals)

• Designing and Developing Products to Meet Patient Needs (PDF - 327KB)
• Q10 Approach to Design (PDF - 769KB)
• Technology Transfer (PDF - 647KB)
• Case Study: Commercial Manufacturing (PDF - 146KB)

Lifecycle Enablers: QRM and KM

Day 2 (Plenary 6: Quality System Enablers: Knowledge Management and Quality Risk Management)

• Case Study: Knowledge Management - An Iterative Process (PDF - 385KB)
• Case Study: Quality Risk Management - Theory and Practice (PDF - 438KB)
• Regulatory Perspective on QRM and Knowledge Management (PDF - 861KB)

Maintaining a State of Control throughout the Lifecycle

Day 2 (Plenary 8: Pharmaceutical Quality System Elements: Process Performance and Product Quality Monitoring System)

• State of Control Over the Lifecycle and Process Validation (New and Legacy Products) (PDF - 378KB)
• Case Study: Lifecycle Input to Support Continued Product Verification and State of Control of the Commercial Scale Process (PDF - 498KB)
• Lifecycle Input to Support Continued Product Verification and State of Control of the Commercial Scale Process- Case Studies (PDF - 453KB)

The Process Performance and Product Quality Monitoring System

Day 2 (Plenary 8: Pharmaceutical Quality System Elements: Process Performance and Product Quality Monitoring System)

• Product Quality Indicators (PDF - 2.3MB)
• Product Quality Management (PDF - 907KB)
• Case Study: Use of Statistical Process Control Approaches to Detect Process Drift; Using Process Capability Measurement (PDF - 1.2MB)