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
Who Will Benefit
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, CMQ/OE is the Principal Consultant at Lean to Quality, LLC. He has more than 30 years of experience in Quality and Regulatory management. Over that time, He has implemented and overseen quality system operations and assured compliance, at all sizes of company, from start-up to more than $100 million in revenue. This multi-faceted experience makes Jeff uniquely qualified to address compliance issues across the entire range of company sizes.
Jeff has also been primary liaison with FDA inspectors and notified body auditors, giving him first-hand experience with the most common issues surfaced by regulatory agencies.
Jeff received his Regulatory Affairs Certification from RAPS, his Manager of Quality and Organizational Excellence certification from ASQ, and his Lean Black Belt from IIE.