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