How to perform a GxP temperature mapping | Full training session скачать в хорошем качестве

How to perform a GxP temperature mapping | Full training session

How do you actually plan, execute, and report a GxP temperature mapping study? In this 2-hour training webinar, Jakob Konradsen – co-founder and Chief Quality Officer at Eupry – walks through the complete mapping process, from protocol writing and sensor placement to data analysis and continuous mapping. This session marks the launch of Jakob's book, "Mastering Temperature Mapping: A Practical Guide for GxP." TIMESTAMPS 00:00 – Introduction and background 03:30 – Why temperature mapping matters in GxP 06:45 – Regulatory requirements (EU GDP, WHO, ISPE) 10:20 – When to perform mappings and remappings 18:00 – The mapping process overview (protocol, execution, reporting) 22:30 – Protocol essentials: purpose, scope, training, facility description 35:00 – Defining acceptance criteria and measurement uncertainty 42:00 – Test strategies: stability, door opening, and power failure studies 52:00 – Minimal vs. maximal loading and seasonal mappings 58:00 – Calibration: accredited vs. traceable, choosing calibration points 1:05:00 – Logging intervals and how they affect data quality 1:12:00 – Sensor placement methodology and risk-based rationale 1:30:00 – Execution: documentation, pictures, and handling non-conformities 1:40:00 – Data analysis: graphs, box plots, and summary tables 1:48:00 – Identifying hot and cold spots for continuous monitoring 1:55:00 – Continuous mapping: eliminating periodic re-qualification 2:05:00 – Live Q&A WHAT YOU WILL LEARN This training covers how to write a mapping protocol that auditors trust, where and why to place data loggers based on risk (not just guidelines), how to analyze mapping data using box plots and statistical methods, how to identify hot and cold spots for continuous monitoring placement, and how continuous mapping can replace costly periodic re-qualification studies. RESOURCES Get a free preview of "Mastering Temperature Mapping": https://eupry.com/temperature-mapping... Temperature mapping guide: https://eupry.com/temperature-mapping/ Continuous mapping explained: https://eupry.com/temperature-mapping... Download the Eupry product catalog: https://eupry.com/product-catalog/ ABOUT EUPRY Eupry provides integrated temperature compliance solutions for pharmaceutical, biotech, and healthcare logistics organizations. One platform for monitoring, mapping, calibration, and validation – replacing the complexity of managing 40+ vendors. Learn more: https://eupry.com Download the product catalog: https://eupry.com/product-catalog/ Follow Eupry: LinkedIn:   / eupry   #temperaturemapping #GxP #pharmaceuticalcompliance