Process Validation Course to learn process design, qualification, and continued verification to maintain pharma quality.
What you will learn
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Fundamentals of manufacturing Process Validation β Understand validation, its purpose, and how it ensures product quality, safety, and compliance in pharma.
Regulatory Guidelines & Compliance β Learn FDA, ICH, WHO, and EU GMP guidelines and how to meet process validation compliance requirements.
Types of Process Validation β Explore Prospective, Concurrent, Retrospective, and Revalidation, and understand when and how to apply each.
Process Validation Lifecycle β Learn the three stages: Process Design, Process Qualification, and Continued Process Verification (CPV).
Equipment & Facility Qualification β Understand IQ, OQ, PQ processes and their role in ensuring equipment and facility compliance.
Validation Protocols & Documentation β Learn how to create, execute, and maintain Validation Master Plans, protocols, and reports.
Critical Process Parameters & Quality Attributes β Identify and control CPPs and CQAs to maintain consistent product quality.
Data Analysis & Statistical Methods β Use control charts, trend analysis, and statistical tools to analyze validation data.
Risk Assessment & Troubleshooting β Identify risks, resolve validation challenges, and ensure smooth pharma manufacturing processes.
Real-World Case Studies β Apply validation concepts in practical industry scenarios with real-world examples.
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