Applying ICH Q9 to Pharmaceutical Quality Systems
About Course
This practical online course moves beyond the theoretical principles of ICH Q9 to provide a hands-on framework for integrating Quality Risk Management (QRM) into your Pharmaceutical Quality System (PQS). Learners will gain a clear understanding of how to apply risk management methodologies to real-world scenarios, enhancing decision-making, optimizing resource allocation, and strengthening overall regulatory compliance.
What You Will Learn:
- Core principles of ICH Q9 and its role within a PQS
- Risk assessment procedure
- Risk assessment methodologies
- Risk-based decisions to internal and external stakeholders
Who Should Enroll:
- QA & QC Professionals
- Production and Process Engineers
- Qualified Investigators
- Auditors and Compliance Personnel
Course Format:
- Self-paced online modules
- Lifetime access
- Quizzes & certification upon completion
Course Content
Module I
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Introduction ICH Q9
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Scope and Principles
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Overview of Quality Risk Management Process
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Pre Assessment-1
Module II
Module III
Module IV
Final Assessment
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