ComplianceOnline

Quality Management System for Equipment Validation, Tracking, Calibration, and Preventive Maintenance

Instructor: Jeff Kasoff
Product ID: 701142
  • 24
  • March 2017
    Friday
  • 10:00 AM PDT | 01:00 PM EDT
    Duration: 60 Min

Live Online Training
March 24, Friday 10:00 AM PDT | 01:00 PM EDT | Duration: 60 Min

$199.00
One Dial-in One Attendee
$449.00
Group-Max. 10 Attendees/Location
(For multiple locations contact Customer Care)

recorded version

$249.00
1x Person - Unlimited viewing for 6 Months
(For multiple locations contact Customer Care)
Recorded Link and Ref. material will be available in My CO Section 48 hrs after completion of Live training

Training CD

$349.00
One CD is for usage in one location only.
(For multiple locations contact Customer Care)
CD and Ref. material will be shipped within 15 business days after completion of Live training

Combo Offers

Live + Recorded Version

$349.00

Live + Training CD

$449.00

Customer Care

Fax: +1-650-565-8542

Email: customercare@complianceonline.com

Read Frequently Asked Questions

This Quality management training will provide valuable assistance in process development include in Equipment Validation, Tracking, Calibration, and Preventive Maintenance.

Why Should You 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!

Areas Covered in the seminar:

  • Equipment Validation: Installation Qualification, Operation Qualification, and Performance Qualification
  • 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

Who will benefit:

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

  • QA management
  • Quality Engineering staff
  • R&D management
  • Engineering management
  • Production management
  • Manufacturing Engineering staff
  • Design engineers
  • Reliability engineers
  • Calibration technicians
  • Maintenance personnel
Instructor Profile:
Jeff Kasoff

Jeff Kasoff
Director of Quality, Medivators

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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