Pharmaceutical Validation, Calibration and Qualification
About Course
Welcome to Pharmastate Academy’s comprehensive course on “Validation, Calibration & Qualification.” Explore the vital role of Validation, Calibration, and Qualification in pharmaceutical production and quality assurance. Objectives include understanding validation principles, exploring calibration intricacies, and mastering equipment, facility, and process qualification for regulatory compliance.
Delve into validation processes, studying life cycles, protocols, reports, and various types. Validation stages, from design to performance, are explained, emphasizing the importance of systematic approaches. Validation protocols and reports, crucial for regulatory transparency, are detailed.
Calibration’s significance is highlighted, distinguishing it from validation. Learn about instruments requiring calibration, procedures, and documentation. Move on to equipment and facility qualification, including IQ, OQ, and PQ. Facility qualification covers cleanrooms and HVAC systems.
Real-world case studies showcase successful validations, calibrations, and qualifications. Explore challenges faced during production changes and method transfers, emphasizing the importance of change control and robust protocols.
Join us to gain practical skills, apply knowledge through case studies, and ensure excellence in pharmaceutical processes. Elevate your career with Pharmastate Academy’s Validation, Calibration & Qualification course!
Course Content
1. Validation, Calibration and Qualification
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1.1 Objectives
03:09 -
Quiz: Introduction
2. Validation Processes
3. Calibration
4. Qualification
5. Examples
6. Final Assessment
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