Equipment Validation, Tracking, Calibration and Preventive Maintenance
10:00 AM PDT | 01:00 PM EDT
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Live: One Dial-in One Attendee
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Recorded: Access recorded version, only for one participant unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
Corporate Recorded: Access recorded version, Any number of participants unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
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:
Who Will Benefit:
- 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
This webinar will provide valuable assistance to all personnel involved in equipment/process development:
- QA Management
- Quality Engineering Staff
- R&D Management
- Engineering Management
- Production Management
- Manufacturing Engineering Staff
- Design Engineers
- Reliability Engineers
- Calibration Technicians
- Maintenance Personnel
Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy and colonoscopy devices, where he oversees the operation of the quality system. In this position, Jeff is responsible for oversight of the document control system, including maintenance of regulatory documentation. Prior to this, Jeff spent 13 years at Life-Tech, Inc. as the Director of Regulatory Affairs, where he was responsible for compliance of the corporate quality system. Jeff received his regulatory affairs certification in 1996.