Categories > Auditing & TQM Category::       Facility & Equipment System Component of the Quality System Inspection     Program Duration : 5 Days Program Date 1 Program Date 2 Program Date 3 : : : 02-06 June, 2012 Cairo, Egypt 07-11 July ,2012 Alexandria Egypt 20-24 October ,2012 Cairo, Egypt Program Fees : US$ 2950/Per Person       Program introduction: The Facilities & Equipment component of the Quality System is as important as the other component – even if it has less attention paid to it. Throughout the lifecycle of a facility or equipment train, all the steps have to be taken with an eye towards compliance to insure “validatability” and maintenance of the validated state. Beginning with project conception, through design, implementation, commissioning, qualification, operation (maintenance, calibration, change control, pest control, cleaning, etc.) and decommissioning, the validated state must be maintained via constant diligence to GMP engineering and operations concepts. This seminar will present requirements for Compliant Engineering, Maintenance, Calibration and associated systems as part of an overall Quality System. It will demonstrate how these functions as the Facilities and Equipment System of the FDA Quality Systems Approach to inspections, are major, though often unheralded, parts of the overall compliance effort.     PROGRAM OUTLINES: Regulatory basis for the Facilities & Equipment component of the Quality System The appropriate role for the Quality Unit throughout the Facilities & Equipment Component The Role of Project Engineering in Compliance – the Engineering Life Cycle Model Facility Auxiliary Programs Basics: Pest Control Cleaning Drawing Control Engineering Change Control Spare Parts (& Lubricants) Technician/Contractor Qualification and Training A Compliant Maintenance Program Work Order Management PM System Control Metrics A Compliant Calibration Program Classifications SOPs Out-of-Tolerance Limits and Tolerances