• Instrument Calibration and Documentation for FDA-Regulated Industries (TI24)


    Course Length:  4.5 Days
    CEUs:  3.2/32 hours


    Do you really want an untrained technician working on equipment that directly affects the quality and integrity of the product being manufactured at your facility? The implications of inaccuracy could easily amount to millions of dollars in product recall or lawsuits, as a result of a defective product. Current statistics show that finding an out of tolerance calibration is a $40,000 investigation!

    This course offers a combination of practical information and hands-on experience, covering fundamental principles of electronic process control instrumentation used in FDA-regulated industries including pharmaceutical and food processes.

    Proper calibration will be covered in hands-on lab exercises using common electronic instrumentation including analyzers. You will examine characteristics of electronic control systems and procedures for configuring transmitters, transducers, and controllers. A good portion of time is spent working hands-on with typical industry equipment.

    Following the course, you will be able to hit the ground running with a better understanding of process control fundamentals and the proper methods of calibration, saving both future organization time and investment.

    Course Prerequisites:

    Basic understanding of FDA industry regulations

    Who should attend?

    Technicians, engineers, supervisors and managers who want to gain a better understanding of the field of process control, and calibration standards necessary in FDA regulated industries

    You will be able to:

    • Select and operate test equipment to measure electrical properties and calibrate instruments
    • Calibrate electronic transmitters
    • Recognize the importance of maintenance in the proper operation of instruments and control systems
    • Use manufacturer's guidelines to configure instruments for specific process applications
    • Use piping and instrumentation diagram (P&ID), wiring, schematic, and installation detail drawings to install, calibrate, and verify proper operation of instruments
    • Explain the relevance of ISO 9000 standards to maintenance practices and procedures
    • Recognize typical calibration needs for systems used in the FDA-regulated industries

    You will cover:

    • Fundamentals of Temperature, Pressure, Flow, Level and Analytics
    • Technical Mathematics
    • Loop Characteristics: Wiring of a two wire series loop
    • Ohm's Law
    • Test Equipment: Multimeter | Process Calibrator
    • Calibration and Configuration: Instrument Performance | Calibration Standards |Device Calibration | Calibration Documentation | Configuring Smart Transmitters
    • Calculating Upper and Lower Range Values on smart devices
    • Instrument Maintenance: Corrective | Preventive | Predictive
    • ISA 5.1 P&IDs & Documentation
    • Standards-Based Calibration Programming
    • CFR 21 Basics
    • Compliance
    • Measurement UncertaintyTolerances & Validated Systems

    Classroom/Laboratory Exercises:

    • Calculate, record, and graph instrument performance data to compare with specifications and identify errors
    • Measure and record voltage, current, and resistance
    • Calculate span and range values for various level measurement applications
    • Calibrate differential pressure, RTD, and thermocouples
    • Configure smart differential pressure and temperature transmitters
    • Calibrate pH and conductivity analyzers