Certificate of Instrument Calibration & Validation

  • This subject will focus on qualification of major pharmaceutical laboratory instrument. The student will learn theory, principle and practices of HPLC, dissolution tester, spectroscopy, balance, viscometer, pH-meter, auto-titrator, oven, thermometer and Karl Fischer titrator calibration and qualification.

    • Introduction

    • Regulation, Standards and Guidelines

    • Design Qualification

    • Installation Qualification

    • Operational Qualification

    • Performance Qualification and Maintenance
       HPLC
       GC
       Dissolution Tester
       Spectroscopy
       Balance
       Viscometer
       pH-meter
       Auto-titrator & Karl Fischer titrator
       Oven
       Thermometer

    • Operational Qualification

    • Reference Standards

    • Audits

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