ISA course covers FDA calibration requirements | Automation.com

ISA course covers FDA calibration requirements

April 7, 2014 - The International Society of Automation (ISA) today introduces a new training course that enables companies regulated by the US Food and Drug Administration (FDA) to meet demanding government requirements for product and process quality and safety.

The new week-long course, Instrument Calibration and Documentation for FDA-Regulated Industries (TI24), offers a combination of practical information and hands-on experience, covering fundamental principles of electronic process control instrumentation used in FDA-regulated industries such as pharmaceutical and food processing and packaging.

Proper calibration is demonstrated in lab exercises using common electronic instrumentation and analyzers that simulate real-world scenarios. Students will examine characteristics of electronic control systems and procedures for configuring transmitters, transducers and controllers. A significant portion of class time is devoted to working with typical industry equipment.

Inaccurate, improper instrument calibration can lead to serious, costly consequences
Gaining a better understanding of process control fundamentals and learning the proper methods of calibration are essential for technicians, engineers, supervisors and managers working in FDA-regulated industries. Product defects as a result of equipment inaccuracies and irregularities can lead to expensive product recalls and lawsuits. A single out-of-tolerance instrument calibration can cost tens of thousands of dollars.

“This new course delivers clear value to instrument technicians working in the pharmaceutical and food processing industries and to the companies that employ them,” says Chuck Kirby, a process control engineering expert who developed the course for ISA and is now teaching it. “From the technicians’ point of view, they gain the fundamental, hands-on instrumentation training that they need to meet highly demanding calibration and documentation criteria mandated of drug and food manufacturers by the FDA. After all, the precise control of temperature, pressure, level and flow is essential when formulating drugs and producing food. If any one of these factors is out of range, product quality is at risk.”

“Of course, product integrity is everything in FDA-regulated industries,” he continues. “Drugmakers, for instance, depend on continuously accurate instrumentation calibration. If there is even a one-minute lapse where an instrument could be out of calibration, the FDA will demand proof that the quality of the medicine has not been affected. In some cases, concerns over product quality will lead to a drug recall and halt in-plant operations, both of which can be financially devastating to the company.”

This new ISA course will teach students 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
  • Rely on manufacturers’ 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

Key subject areas covered include:

  • Fundamentals of temperature, pressure, flow, level and analytics
  • Calibration and configuration
  • Instrument maintenance
  • Standards-based calibration programming
  • Measurement uncertainty, tolerances and validated systems

Classroom and laboratory instruction includes:

  • Calculating and monitoring of instrument performance data to compare with specifications and identify errors
  • Measuring and recording of voltage, current and resistance
  • Calibrating differential pressure, RTD and thermocouples
  • Configuring smart differential pressure and temperature transmitters
  • Calibrating pH and conductivity analyzers

Upcoming course dates and locations

Instrument Calibration and Documentation for FDA-Regulated Industries (TI24)
5–8 May 2014
Ives Equipment Corporation
King of Prussia, PA USA

Instrument Calibration and Documentation for FDA-Regulated Industries (TI24)
2–6 June 2014
ISA Headquarters
RTP, NC USA

Instrument Calibration and Documentation for FDA-Regulated Industries (TI24)
8–12 September 2014
TBD

Instrument Calibration and Documentation for FDA-Regulated Industries (TI24)
8–12 December 2014
ISA Headquarters
RTP, NC USA

To register for the June 2014 offering of T124, visit the course registration page. Please note that class size is limited, and registrations will be filled on a first-come-first-served basis.

About the course developer and instructor
A Senior ISA member and an ISA Level III Certified Control Systems Technician (CCST), Chuck Kirby is highly experienced in troubleshooting, repair, calibration, design, installation and modification of process instruments and electrical controls associated with industrial and municipal operations.

Once featured in Control Engineering magazine for his work in process control for the US Department of Defense, he has expertise in project management, scheduling, technical writing, quoting, specifying, engineering, CAD, course development and training.

Over the course of his career, Kirby has worked with: the US Army as an electronic technician, Honeywell as a field service engineer and branch manager, the International Brotherhood of Electrical Workers (IBEW) as an instrument and control technician, and Wyeth Pharmaceuticals as a plant-wide process controls specialist.

About ISA
Founded in 1945, the International Society of Automation is a leading, global, nonprofit organization that is setting the standard for automation by helping over 30,000 worldwide members and other professionals solve difficult technical problems, while enhancing their leadership and personal career capabilities. Based in Research Triangle Park, North Carolina, ISA develops standards; certifies industry professionals; provides education and training; publishes books and technical articles; and hosts conferences and exhibitions for automation professionals. ISA is the founding sponsor of The Automation Federation.

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