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 a product that meets its specifications. There are ways, though, to validate equipment already in use.
This webinar will provide instruction on how to establish and maintain a Maintenance & Calibration program for medical device and pharmaceutical instrumentation & equipment.
Areas Covered in the Session :
- Definitions and Regulatory Expectations
- Preventive Maintenance Requirements
- Equipment Calibration Requirements
- Calibration vs. Maintenance: When to use Which One?
- Intervals for maintenance and calibration.
- Maintenance and calibration procedures.
- Remedial Action for Out-of-Calibration Equipment
- Use of Calibration Standards for Efficiency and Accuracy
Who Should Attend:
- Quality Departments
- Engineering Departments
- Research and Development Departments
- Production Departments
- Manufacturing Departments
- Validation Departments
- Operations Departments
- Design Engineers
- Reliability Engineers
- Calibration Technicians
- Maintenance Personnel
FDB3524
