Best Practices for Equipment Validation, Tracking, Calibration, and Preventive Maintenance

Why Should You Attend:

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. However, there are ways to validate equipment already in use!

Areas Covered in the seminar:

• 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

Frequently Asked Questions:

1. How to initiate the change request required for relocating the equipment?
2. So, by definitions, you mean that we needs to define the Qs specifically for the purposes of what our validation is?
3. What is the main difference between the Validation and Qualification?
4. Equipment’s calibration was missed out to perform as per schedule during this pandemic, in this scenario shall we write the deviation? And deviation is acceptable by regulatory?

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
Director of Quality, Medivators

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.

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