Best Practices for Equipment Validation, Tracking, Calibration, and Preventive Maintenance
Jeff Kasoff, RAC, CMQ/OE has more than 30 years of experience in Quality and Regulatory management. Over that time, Jeff 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 the 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. He is also a certified internal auditor for MDSAP, ISO 13485:2016, and EU MDR, from Exemplar Global.
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 session will review the regulatory requirements for validation, including a detailed review of IQ, OQ, and PQ. A sample validation process will be followed through each phase. Documentation requirements for both protocol and results will be reviewed, as well as a list of pitfalls to avoid in documenting your validation. The importance of the Master Validation Plan will be discussed. Preventive maintenance will be covered, including how to assure it does not adversely impact validated processes. A cost-effective equipment calibration program will be featured as well.
- Types of Validation
- The Validation Sequence
- Installation Qualification
- Operation Qualification
- Performance Qualification
- Equipment Calibration: Frequency and How to Reduce It
- Understanding of Calibration Traceability
- Use of Calibration Standards for Efficiency and Accuracy
- Benefits of Equipment Calibration Outsourcing
- Calibration Remediation Requirements
Course Level - Intermediate
Who Should Attend
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
Why Should You Attend
devices and pharmaceutical products must be safe and effective.
Equipment used in assembly, test, or measurement must be able to be used
for its intended purpose and result in a product that meets its
required specifications. It is not cost-effective to routinely measure products to evaluate conformance to all specifications. It is,
therefore, critical to have an in-depth understanding of the methods for
establishing equipment and corresponding processes that assure product
output on a routine basis.