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02-Oct-2019 - 03-Oct-2019

Facility, Maintenance and Calibration Considerations of the Quality Systems Inspection Technique (QSIT)

  • Location:
    • Venue to be announced shortly
    • Philadelphia
    • Pennsylvania
    • 19019
    • United States
  • View on a map

Attend this seminar to learn the concepts for developing compliance programs to maintain the validated state. These programs are included in the Six-system Inspection Model of the Facility portion of the FDA Guidance For Industry – Quality Systems Approach to Pharmaceutical Current Good Manufacturing Practice Regulations. Topics include GMP Maintenance, Calibration, Pest Control, Replacement Parts, and Project Engineering/Engineering Document Control.

Learning Objectives:

  • To understand the ongoing requirements of facilities, maintenance, and calibration systems to maintain the validated state of equipment and facilities.
  • Understand requirements for a complaint Project Engineering Program
  • Instituting a Compliant Maintenance Program
    • Developing Preventive Maintenance Regimen
    • Handling Demand (Corrective) Maintenance Requirements
    • Handling late PM assignments
    • Maintenance Metrics
  • Instituting a Complaint Calibration Program
    • Developing Calibration Parameters:
      • Classifications
      • Limits and tolerances
      • Frequency of Calibration
    • Out-of-Tolerance responses
    • Calibration Metrics
  • Ensuring an adequate Pest Control Program
    • Location and types of Pest Control Devices
    • Monitoring, reporting and responding to Pest Control issues
  • Requirements for replacement parts
    • Types of replacement parts
    • Approving Functional Equivalent (Like-for-Like) Parts
  • Technical Document Control
  • Storing and controlling Manuals and Drawings

Areas Covered :

GMP Facilities, Project Engineering, Maintenance, and Calibration

Who will Benefit:

Operations, Engineering, Maintenance, Calibration and support personnel in the FDA regulated industry