Equipment Validation, Tracking, Calibration, and Preventive Maintenance

Product Id : 600129

Globalcompliancepanel

Training Options

  •   Duration: 60 Minutes  
  • Recorded Access recorded version only for one participant; unlimited viewing for 6 months ( Access information will be emailed 24 hours after the completion of live webinar)
    Price: $295.00
  • Refund Policy

Overview:

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 Session:

  • 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

Who Will Benefit: This webinar will provide valuable assistance to all personnel involved in process development:

  • R&D management
  • Engineering management
  • Production management
  • Production engineers
  • R&D engineers
Jeff Kasoff, RAC, CQM, is the Director of Quality at Medivators, a leading manufacturer of consumables and instrumentation in the endoscopy field. Among his responsibilities is oversight of the document control system. In his 20+ years of Quality and Regulatory management, Jeff has implemented and overseen document control systems at all sizes of company, from startup to $100 million in revenue. Over that time, he has also been primary liaison with FDA inspectors and notified body auditors. Jeff received his regulatory affairs certification in 1996, and his certified quality management certification in 2013.


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