Thermal mapping and qualification of storage enclosures for health products. Run a qualification from start to finish — and defend your verdict before an auditor.
Defrost excursion consistent with the declared cycle (8 episodes for ≈8 expected at 6 h). Continued monitoring recommended.
Vaccines and temperature-sensitive medicines require qualified enclosures. Every degree counts, and every enclosure must be measured, verified and validated.
For adsorbed vaccines, freezing is irreversible: a frozen vaccine cannot be recovered by thawing.
Heat damage is cumulative, and most often irreversible — hence the need for a cumulative indicator, the MKT.
Without a traceable, defensible report, compliance cannot be demonstrated to an authority or a funder.
Not an awareness session: an operational capability, practised on realistic qualification scenarios.
Conduct a thermal mapping following WHO methodology and GDP requirements.
Place sensors according to the field convention, record the geometry and the door.
Return a reasoned verdict — and tell what judges the enclosure apart from what raises an alert on the product.
Produce a compliant, traceable report, and defend it before an auditor.
Five modules with one quiz each at an 80% pass mark, and 10 exercises on realistic qualification scenarios, at a 70% pass mark.
Why map, the reference framework (WHO TRS 961, GDP, PQS, USP, ISO/IEC 17025), temperature, humidity, indicators, metrology.
Qualification, mapping and monitoring; the four types of mapping; IQ / OQ / PQ; the criteria and the consolidated verdict rule.
Prepare the protocol, configure the mission, declare sensors and geometry, metrology, import, 3D / 2D map, report generation.
Choose and prepare loggers, deploy them following the sensor plan, export the data, data integrity.
Anatomy of the report, defensible conclusions and recommendations, defending the report in an audit, export and archiving.
Five quizzes at 80% or more and at least 7 of the 10 exercises at 70% or more. The certificate bears your name and the date it was obtained, and you are entered in the KERNIZ PLUS register of certified learners.
A qualification report does not say “it's fine” or “it's not fine”. It returns one of these three verdicts, and gives its reason.
The enclosure is under control. All acceptance criteria are met. A tolerated excursion may exist — it is then named, and continued monitoring is recommended.
Usable, with conditions. A trigger is active. The enclosure remains usable until the due date, provided the corrective actions are cleared.
Report not valid as it stands. A prerequisite (metrology, geometry) or a blocking criterion has failed. The enclosure must be corrected, then re-mapped.
You will also learn what does not vote on the verdict: the margin to limits is a robustness indicator, and the product risk alert triggers a stock investigation without judging the enclosure. Two separate decisions, taken by two different people.
The training is built on the tool you will use on missions. You do not leave with notes: you leave with a method and an instrument.
4 corners × 3 levels principle; WHO TRS 961 Annex 9 Supplement 8 and USP <1079.4>.
Integrated temperature / RH qualification: with thermohygrometers, humidity is assessed against a budget.
Tells a defrost cycle from an excursion — on prior declaration, never after the fact.
MKT by sensor, freezing and heat-peak markers, enclosure plan and door position.
The institutional decision is added as an appendix; it never alters the technical verdict.
Numbered, versioned, with a signature page — in French or English, ready for a quality file or a funder.
100% online, two months of access, live sessions twice a week for questions and clarifications.
Independent or employed professionals
EPI, central medical store, NGO, programme
On-site qualification mission
Doctor of Pharmacy · Cold chain and health logistics consultant
Twenty years of practice in vaccine logistics, enclosure qualification and supply chain management, with field missions in ten African countries. Designer of QualiTemp Pro, born from what the field reveals when the standard is silent.
Leave able to run an enclosure qualification on your own, from start to finish — and to defend your verdict.