Scope

This training program provides comprehensive instruction on the calibration, verification, and management of temperature-measurement devices used in pharmaceutical, biologics, vaccine, medical-device, food, and healthcare distribution environments.

Environments covered include:

• Warehouses and distribution centers
• Refrigerated warehouses and cold rooms
• Freezers (including –20°C, –40°C, and –80°C)
• Refrigerated trucks and trailers
• Temperature‑controlled transportation systems (active and passive)
• Continuous monitoring systems (CMS)

Devices covered include:

• Resistance Temperature Detectors (RTDs – Pt100, Pt1000)
• Thermocouples (Types J, K, T, E, N, S, R)
• Thermistors (NTC and PTC)
• Digital thermometers
• Infrared thermometers
• Data loggers (single‑use and reusable)
• Fixed and wireless sensors
• Temperature mapping sensors

Excluded from scope: Laboratory analytical instruments (e.g., HPLC, UV‑Vis spectrophotometers) unless used as reference standards for temperature measurement.

Learning Objectives

Upon successful completion, learners will be able to:

• Identify and apply calibration requirements from WHO TRS 961, EU GDP, 21 CFR Parts 210/211/205, Health Canada GUI‑0069, and ISO 17025.
• Explain key metrological concepts including accuracy, precision, repeatability, reproducibility, resolution, stability, drift, linearity, hysteresis, and measurement uncertainty.
• Differentiate between RTD, thermocouple, thermistor, and digital thermometer technologies and select appropriate calibration methods for each.
• Execute a complete multi‑point calibration procedure from planning through labeling and record retention, including error calculation using acceptance criteria.
• Calculate expanded measurement uncertainty and determine whether a device is suitable for its intended use.
• Investigate out‑of‑tolerance (OOT) events using root cause analysis and implement effective corrective and preventive actions (CAPA).
• Apply ALCOA+ principles to calibration records and ensure data integrity for electronic and paper‑based systems.
• Prepare for regulatory inspections by organizing calibration documentation and responding to common auditor questions.
• Troubleshoot at least five common calibration failure scenarios using case study methodology.
• Pass all module assessments with a score of 80% or higher and complete the final case study evaluation.

Target Audience

Certification

Learners who successfully complete the program will receive a dated, traceable certificate that provides verifiable proof of their achievement for professional records.