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