Warehouse Temperature Mapping: Risk-Based Validation For Gxp
 

What you'll learn
How to perform a risk-based warehouse mapping study
How to identify worst-case sensor locations
How to think critically about your space, environment, and risks
When and how often to perform mapping (initial, seasonal, requalification)
How long to run your mapping study (24, 48, 72+ hours - and why)
The difference between initial qualification, requalification, and periodic monitoring
Pre-mapping preparation steps - including warehouse walkdown, layout review, load simulation, and zone identification
How to ask the right questions before protocol writing
How to connect your observations, rationale, and data to your protocol and final report
Sensor placement strategies for warehouses
Mapping temporary and active storage zones
How to analyze data and define qualified space
Handling temperature excursions and writing CAPAs
Documenting and reporting for audit readiness
Warehouse walkthrough strategy before protocol creation
Understand how loading, HVAC, and warehouse layout affect your data
Reflect your reasoning clearly in documentation
Predict problem areas before failures happen
Evaluate vertical and horizontal airflow differences
Requirements
Basic understanding of GMP/GDP principles
No technical tools required - templates and diagrams included
A willingness to think beyond checklists
Description
Are you responsible for temperature-controlled storage, GxP-compliant warehouses, or product stability across critical storage areas?This course is your complete practical guide to designing and executing temperature mapping studies in warehouses and storage environments - based on ISPE, WHO, HPRA, and GMP guidelines.Learn not just what the regulations say - but how to apply them in the real world. What You'll Learn: • The ISPE-compliant approach to temperature mapping for warehouses • How to determine the number and placement of sensors • Risk-based frequency of mapping and how to justify your intervals • Mapping near HVAC vents, doors, ceilings, floors, and external walls • Dealing with temporary storage areas and ensuring compliance • How to interpret climatic influences (e.g., hot days, windows, human activity) • How to perform a walkthrough risk assessment before mapping • Real examples of sensor layout, shift patterns, and mapping duration planning Designed For: • Quality professionals and validation engineers • Warehouse & logistics managers in pharma and healthcare • GDP/GMP compliance teams • Regulatory auditors and inspectors • Beginners seeking a clear, simplified approach to validationWhy Take This Course?This is not a theory-heavy lecture. It's a practical walkthrough, showing you exactly how to plan and execute your mapping using industry guidelines and real-world logic.You'll leave with: • A clear strategy to defend your mapping plan in audits • Tools and checklists to guide your next mapping study • Confidence in implementing GxP-compliant storage validation Course Features: • Clear video walkthroughs (no fluff!) • Templates and practical tools (PDFs, layouts, examples) • Visual mapping plans and animated explanations • 24/7 instructor Q&A supportBy the end of this course, you'll be ready to plan, execute, and document a temperature mapping study in any warehouse - confidently and in full compliance.Enroll now and take the guesswork out of temperature mapping.
Who this course is for
Quality Assurance (QA)/Validation professionals in pharma, biotech, medical devices, healthcare
Cold chain warehouse operators and GxP facility owners
Regulatory compliance leads and auditors
Anyone preparing protocols or reports for temperature mapping
Validation engineers and specialists
GxP facility managers
Anyone responsible for mapping or qualifying temperature-controlled spaces