C4A – Equipment Validation, Tracking, Calibration and Preventive Maintenance

April 20, 2021 @ 10:00 am – 11:00 am


By Jeff Kasoff


FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment. 

The program must include: intervals, scheduling, specific procedures, limits of accuracy/precision, and remedial action in the event that the equipment does not meet established requirements. 

Areas Covered in the Session:

  • Equipment Validation: Installation Qualification, Operation Qualification, and Performance Qualification
  • Preventive Maintenance Requirements
  • Calibration vs. Maintenance: When to use Which One?
  • Remedial Action for Out-of-Calibration Equipment
  • Use of Calibration Standards to Save Cost
  • Equipment Calibration Requirements: Scheduling, Use of External Services, and Documentation
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