C4A – Equipment Validation, Tracking, Calibration and Preventive Maintenance

January 16, 2020 @ 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. 

Prior to use, however, this equipment must be validated to make sure it produces product that meets its specifications. There are ways, though, to validate equipment already in use. 

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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