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

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training seminars by ComplianceOnline ComplianceOnline

Facility, Maintenance and Calibration Considerations of the Quality Systems Inspection Technique (QSIT) seminar agenda print utility

dates/locations

For:

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

Cost:   

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Seminar Summary:

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. (see full course description)

 

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Training Course Syllabus:


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


    Areas Covered :


    GMP Facilities, Project Engineering, Maintenance, and Calibration


Seminar Summary:

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. (see full course description)

 

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