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 too. 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.
Why Should You Attend
Medical 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 product 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.
Webinar Takeaway
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 too. 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.
Why Should You Attend
Medical 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 product 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.
Webinar Takeaway
- Equipment Validation
- Installation Qualification
- Operational Qualification
- Performance Qualification
- Equipment Calibration
- Use of Calibration Standards for Efficiency and Accuracy
- Remedial Action for Out-of-Calibration Equipment
- Calibration vs. Maintenance: Which One?
- Equipment Maintenance
Learning Objectives
- Types of Validation
- The Validation Sequence
- Calibration Frequency and How to Reduce It
- Understanding of Calibration Traceability
- Benefits of Equipment Calibration Outsourcing
- Calibration Remediation Requirements
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, CMQOE, RAC
Regulatory Compliance and Quality Assurance ► FDA QSR, ISO 13485/9001 ► Operational Excellence -Remote Consultations
York, Pennsylvania, United States
Jeff Kasoff, RAC, is the Director of Regulatory Affairs at Life-Tech, Inc., a leading manufacturer of consumables and instrumentation in the urodynamic and pain management fields. Jeff is responsible for oversight of corporate compliance with domestic and international regulations, preparation of submissions, and is primary liaison with regulatory agencies and notified bodies. 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.
