Mastering Temperature Mapping
A Complete Practical Guide (and a take on the future of GxP)
One book. All the guidelines. Real use cases.
Jakob Konradsen spent two years writing the temperature mapping textbook he wished existed: every standard, practical guidance, and a roadmap for continuous compliance.
A mapping guide that bridges guidelines and real practice
“Mastering Temperature Mapping” bridges the gap between guidelines and the real world. In the book, Jakob Konradsen distills over a decade of mapping experience into methods you can use right away – from protocol writing to logger placement and reporting.
The book:
- Goes beyond guidelines with experience from 10+ years of thermal validation
- Provides risk-based, step-by-step frameworks for protocols, placement, and reports
- Explains, in detail, the underlying risks that the guidelines are based on
What you will get
All relevant standards
What ISPE, WHO, USP, FDA, EMA, and PIC/S actually require for temperature mapping and validation.
Practical examples
Sensor placement, study design, acceptance criteria, documentation, and common pitfalls.
Risk-based approach
When to map, how to decide how often to re-map, and how to justify your decisions to auditors.
Continuous mapping
Why the industry is shifting from periodic studies to continuous verification, and how to implement it.
How many guidelines do you cross-reference for a single temperature mapping project?
ISPE, WHO, USP, FDA, EMA, PIC/S...
This book covers them all. Combined with a decade of hands-on mapping experience.
Get the book now
Buy your version of "Mastering Temperature Mapping" now - choose between Ebook or the physical book.