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Equipment Validation, Tracking, Calibration, and Preventive Maintenance  

Date & Time: Thursday, October 20, 2011

10:00 AM PDT | 01:00 PM EDT

Duration: 60 Minutes

Instructor: Jeff Kasoff

Location: Online

Price : $245.00

 

  

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Instructor Profile:

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.

Areas Covered in the Session: l

l l l l l

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

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Jeff Kasoff Director of Regulatory Affairs, Life-Tech, Inc Jeff Kasoff, RAC, is the Director of Quality at Byrne Medical, a leading manufacturer of endoscopy products. In this position, Jeff is responsible for supplier management, during which he reviews and approves supplier qualification, selection, assessment, and CAPA. Prior to this, Jeff spent 13 years at Life-Tech as the Director of Regulatory Affairs, where he was responsible for regulatory compliance of all aspects of the quality system. Jeff received his regulatory affairs certification in 1996. ...more

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

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

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Equipment Validation, Tracking, Calibration, and PreventiveMaintenance