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

Speaker

Instructor: Jeff Kasoff
Product ID: 701786

Location
  • Duration: 60 Min
This webinar will discuss the different aspects which auditors generally look in equipment calibration, maintenance and validation and highlight the best practices.
RECORDED TRAINING
Last Recorded Date: May-2015

 

$50.00 $229.00 (78%)SAVE: $179.00
1 Person Unlimited viewing for 6 month info Recorded Link and Ref. material will be available in My CO Section
(For multiple locations contact Customer Care)

$149.00 $399.00 (62%)SAVE: $250.00
Downloadable file is for usage in one location only. info Downloadable link along with the materials will be emailed within 2 business days
(For multiple locations contact Customer Care)

 

 

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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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Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance. ComplianceOnline would process/provide refund if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs. Substitutions can happen any time. On-Demand Recording purchases will not be refunded as it is available for immediate streaming. However if you are not able to view the webinar or you have any concern about the content of the webinar please contact us at below email or by call mentioning your feedback for resolution of the matter. We respect feedback/opinions of our customers which enables us to improve our products and services. To contact us please email [email protected] call +1-888-717-2436 (Toll Free).

 

 

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