Temperature Mapping Study (Classroom, 3 days)

About

Temperature mapping is a process of identifying the differences and changes in temperature that occur within a designated storage area. A temperature mapping exercise for any new temperature-controlled storage area shall be carried out before its use, according to the international regulations such as WHO, EU Good Distribution Practices Guidelines (GDP) and International Society for Pharmacoepidemiology (ISPE). During this course you will gain theoretical and practical knowledge on how to conduct a temperature mapping study related to storage areas designated for temperature-controlled healthcare products.

This course is available at IATA Training Centers and Regional Training Partner locations, and on-demand as in-house training.

Course code: TCGT-15

Course format

• This classroom course provides 3 days (24 hours) of instruction delivered by an official IATA Instructor.
• Student performance will be based on an assessment.

Prerequisites

• Participants are recommended to have prior knowledge of GDP for pharma and healthcare products.
• Recommended level is Intermediate and Advanced.
• The recommended level of language proficiency is ICAO Operational Level 4 for courses in English or the equivalent level for other languages.

How to register

• To attend a class scheduled at one of our training centers: Register early and save up to 20%! Please read the Terms for the early bird discount. The discount will be calculated at the time of payment.
• To arrange in-house training for your company: Complete the in-house training request form or contact the salesperson in your region.

What you will learn

Upon completing this course you will be able to:

• Enhance your understanding of pharma specific requirements in the area of in-transit and/or cross dock storage
• Provide insights in practical application and enhance audit readiness
• Discuss regulatory requirements, national and international related to storage of Time and Temperature Sensitive Pharmaceutical Products (TTSPPs)
• Identify levels of application of these requirements for GHAs, airlines and forwarders in air freight supply chain
• Relate practical insight from mapping study Protocol preparation to final Temperature mapping Report
• Select the best strategy for deciding on type and number of EDLMS, where to place control devices according to risk assessment

Course content

• Regulatory requirements for storage of medicinal products
• General requirements for storage areas for Time and Temperature Controlled Products
• Use of Electronic Data Logging Monitor (EDLMS)
• Pharma specific storage area requirements
• Temperature mapping study preparation and execution

Activities

• Group exercises
• Practical review

Who should attend

This course is recommended for:

• Pharma responsible personnel
• Quality assurance managers
• Warehouse and operation managers

Certificate awarded

An IATA Certificate of Completion is awarded to participants obtaining a grade of 70% or higher on all exercises and exams. A special distinction is awarded to participants obtaining a grade of 90% or higher.