The course covers the ICH Q10 Pharmaceutical Quality System (PQS), emphasizing an integrated, lifecycle-based approach to pharmaceutical quality management. It highlights how PQS encompasses the entire product lifecycle, ensures quality, supports continual improvement, and aligns with regulatory expectations. The framework promotes a science- and risk-based approach, integrating quality risk management (Q9), process understanding (Q8), and change management, with the goal of ensuring product quality, patient safety, and operational excellence
Created by Dr. YASSER MEKKY
EN/AR [Auto]
Join Now| # | Content |
|---|---|
| 1 | Introduction and Regulatory Framework |
| 2 | Management Responsibilities |
| 3 | Four Key PQS Elements: |
| 4 | Integrating Knowledge Management and Quality Risk Management across all stages. |
| 5 | Applying the system through pharmaceutical development, technology transfer, commercial manufacturing, and product discontinuation. |
| # | Outcomes |
|---|---|
| • Describe the components and key features of ICH Q10 PQS. | |
| Apply risk management principles (Q9) in quality system activities. | |
| Develop strategies for managing product life cycle and process improvements. | |
| Recognize the importance of knowledge management, change management, and audit/inspection readiness within PQS. |
| # | Participants |
|---|---|
| 1 |
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Quality Assurance (QA) and Quality Control (QC) professionals and managers
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| 2 |
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• Regulatory Affairs and GMP Compliance personnel
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| 3 |
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• Manufacturing and Operations managers
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| 4 |
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• Validation, Engineering, and Technical Services (MSAT) staff
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| 5 |
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• CAPA, Deviation, and Investigation specialists
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| 6 |
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• Internal and Supplier Quality Auditors
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| 7 |
S
Senior Management and PQS system owners responsible for management reviews
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| 8 |
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• Research and Development (R&D) scientists working on pharmaceutical development and technology transfer
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