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Equipment Validation, Tracking, Calibration, and Preventive Maintenance

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: US$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
Speaker Profile
Jeff Kasoff, RAC, CMQ/OE has more than 30 years 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 startup 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 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.


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