FDA and EU regulations require that firms have a program for the calibration and maintenance of test and measurement equipment.
The program must include:
- Specific procedures
- Limits of accuracy/precision
- 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 during 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
Director of Quality ,
Jeff Kasoff, RAC, is the Director of Quality at Medivators, a leading manufacturer of endoscopy consumables and instrumentation. In this position, Jeff is responsible for oversight of the quality system, including the CAPA program, and is the liaison with FDA. For the previous 13 years, Jeff served as Director of Regulatory Affairs at Life-Tech, Inc., in which capacity he was similary responsible for quality system oversight. Jeff began his regulatory career as the first full-time employee of Optex Biomedical, a device start-up, where he initiated their regulatory policies and procedures and prepared their submissions. Jeff received his Regulatory Affairs Certification in 1996.
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