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