Equipment Calibration, Maintenance, and Validation: What Auditors Look for in a Controlled Process

Why You Should 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!

This webinar will discuss Equipment Calibration Requirements, Preventive Maintenance Requirements, when to use Calibration when to use Maintenance, what is Remedial Action for Out-of-Calibration Equipment, how to use of Calibration Standards to Save Cost.

Areas Covered in the Webinar:

• Equipment Validation: Installation Qualification, Operation Qualification, and Performance Qualification.
• Equipment Calibration Requirements.
• Equipment 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.
• Equipment Preventive Maintenance Requirements.
• Use of Calibration Standards to Save Cost.
• Remedial Action for Out-of-Calibration Equipment.
• Calibration vs. Maintenance: Which One?
• Equipment Validation: Installation Qualification, Operation Qualification, and Performance Qualification.

Who Will Benefit:

This webinar will provide valuable assistance to all personnel involved in process development or equipment calibration/maintenance:

• R&D management
• Engineering management
• Production management
• Production engineers
• R&D engineers

Instructor Profile:

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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