Catalogue

Ten courses, one vertical

The catalogue is narrow on purpose. Every code sits inside temperature-controlled storage, distribution or air handling of medicines, medical devices and clinical supplies. Participants share a vocabulary: GDP, PIC/S, IQ/OQ/PQ, mapping, kinetic mean temperature, passive shipper qualification, lane risk, excursion files, logger calibration, IATA TCR, dry ice UN1845, ULD build-up, GDPMDS, IMP returns and cryogenic hold. Adjacent topics such as general leadership or open-ended supply-chain theory are left out so a two-day room can finish a protocol rather than a survey.

Storage Distribution Air Clinical Audit

GDP-101

2 days · Group cap: 14

Good Distribution Practice Foundations for Temperature-Controlled Goods

GDP-101 walks a temperature-controlled warehouse from goods-in to dispatch against the PIC/S GDP Guide. Participants map who owns receiving checks, probe placement, alarm response and the documents a consignee will request after a delay. The two days stay inside 2–8 °C, 15–25 °C and frozen lanes used for medicines and related goods in Singapore. Classroom work uses receiving checklists, mapped-storage diagrams and a night-time alarm case so store, QA and distribution roles can see the same failure from three desks.

What we cover

Storage condition labelling versus the actual mapped envelope of a chamber
Goods-in checks, quarantine holds and release under a GDP quality system
Routine monitoring, alarm bands and after-hours response ownership
Pest control, cleanliness and segregation that affect temperature-controlled SKUs
Dispatch, collection and the documents that travel with a shipment
Deviation, complaint and recall interfaces that warehouse teams actually touch

Who it suits. Store supervisors, QA officers and distribution planners who release or hold temperature-controlled stock. Useful as a common language course before mapping, excursion or audit modules.

Prerequisite. No formal prerequisite. Participants should know their own receiving and dispatch steps well enough to describe them in class.

Assessment. Written paper of 20 questions (pass mark 70%) plus a short receiving-and-hold exercise against a sample shipment file.

Audience: warehouse, QA, distribution · Storage

MAP-210

2 days · Group cap: 14

Temperature Mapping and Qualification of Cold Rooms and Chambers (IQ/OQ/PQ)

MAP-210 treats mapping as a qualification activity, not a once-off plot of pretty contours. Participants draft a protocol covering empty-chamber and loaded states, sensor coordinates, logging interval, door-opening challenges and acceptance tied to the labelled range. IQ, OQ and PQ are separated so installation evidence is not mixed with performance under load. The class reads traces against floor plans, names the worst-case sensor, and records why a probe may be excluded. Work stays on 2–8 °C rooms, freezers and small chambers used for medicines and devices.

What we cover

Protocol content: number of sensors, coordinates, interval and empty versus loaded runs
IQ evidence for chamber, controller, probes and documented set-points
OQ challenges including door openings, defrost and power-loss where justified
PQ under representative load and seasonal or ambient extremes available in Singapore
Worst-case location, kinetic load and placing of routine monitoring probes
Report structure, deviations during mapping, and re-mapping triggers

Who it suits. Validation engineers, facility technicians and QA reviewers who approve mapping reports. Warehouse leads who must live with the probe positions afterwards also benefit.

Prerequisite. GDP-101 or equivalent familiarity with labelled storage ranges and a site floor plan of the chamber under discussion.

Assessment. Written paper (70%) plus a practical: build a mapping protocol for a stated 2–8 °C room including sensor layout and acceptance.

Audience: engineers, validation, QA · Storage

PSL-120

1 day · Group cap: 14

Passive Shipper Selection and Lane Qualification

PSL-120 covers how a passive shipper is chosen for a stated payload, duration and ambient profile rather than by catalogue photograph. Participants compare PCM and water-based packs, payload-to-coolant ratios and lid discipline, then set a qualification plan for a lane that may idle on the tarmac. Singapore heat, apron time and a 42-hour example are used as the working envelope. The day ends with a lane risk assessment that names hand-off points, data-logger placement and what evidence the receiving QA group should demand.

What we cover

Shipper families, PCM versus water ice, and payload volume limits
Pack-out instructions, conditioning of coolants and close-out photographs
Lane duration, ambient profiles and summer/winter or monsoon assumptions
Operational qualification of a shipper against a written protocol
Logger placement, start-up delay and stop conditions at goods-in
Lane risk assessment, hand-offs and requalification after a process change

Who it suits. Packaging engineers, 3PL lane planners and customer-service staff who select or defend a shipper for a customer lane.

Prerequisite. Working knowledge of 2–8 °C or 15–25 °C labelled goods. GDP-101 is recommended but not required.

Assessment. Written paper (70%) plus selection of a shipper and pack-out for a 42-hour lane with a stated payload.

Audience: logistics, packaging · Distribution

EXC-130

1 day · Group cap: 14

Excursion Handling and Deviation Investigation

EXC-130 starts when a logger or an alarm says the product left the labelled band. Participants practise gathering the file before anyone guesses: logger configuration, calibration due date, probe position, pack-out photograph, airway bill and the time stamps from each hand-off. Kinetic mean temperature is used as a supporting calculation, never as a silent pass. The class writes a deviation, requests stability or technical input in a form a QP or responsible person can use, and records the disposition. Singapore import lanes and last-mile van delays supply the timelines.

What we cover

What counts as an excursion versus a documented controlled deviation
Evidence pack: logger files, calibration, pack-out and transport timestamps
Use and limits of kinetic mean temperature and mean kinetic temperature tables
Stability statements, manufacturer input and what QA may decide locally
Customer notification, quarantine and the language of a disposition letter
CAPA that changes pack-out, lane or monitoring rather than restating the event

Who it suits. QA reviewers, customer-service leads and warehouse supervisors who hold stock and write the first deviation draft.

Prerequisite. Ability to read a time-temperature file. GDP-101 or site GDP induction is recommended.

Assessment. Written paper (70%) plus close-out of a supplied excursion file with a written disposition and CAPA seed.

Audience: QA, customer service · Distribution

LOG-140

1 day · Group cap: 14

Data Loggers, Calibration and Alarm Configuration (hands-on)

LOG-140 is a bench day. Participants configure USB and Bluetooth loggers, set sample intervals, delay starts and alarm bands that match a 2–8 °C or 15–25 °C specification, then download and read the file. A reference thermometer is used for a spot check so calibration status is not a sticker on the case. Gaps, clock drift, stopped channels and a probe left in the corridor are treated as data-integrity problems. Alarm delays for door openings are set in writing so the night team is not trained to ignore every beep.

What we cover

Logger types, sample interval, start delay and stop conditions
Alarm bands, hysteresis and door-opening delay documented in SOP
Calibration certificates, due dates and a spot check against a reference
Download, file integrity, time zone and clock synchronisation
Gap analysis when a channel stops or a logger is returned late
Placement in chambers, vehicles and passive shippers

Who it suits. Warehouse technicians, engineering staff and QA monitors who issue, place and retrieve loggers.

Prerequisite. Comfort with a laptop USB port and a basic warehouse SOP. No instrumentation degree required.

Assessment. Written paper (70%) plus a practical: configure, run a short exercise and interpret a file that contains a gap.

Audience: warehouse, technical service · Storage

AIR-150

1 day · Group cap: 14

Air Freight of Pharmaceuticals: IATA TCR, ULD Handling and Dry Ice (UN1845)

AIR-150 reads the IATA Temperature Control Regulations as a working document for booking, acceptance and ramp handling out of Singapore. Participants practise the information a shipper must give an agent, how a ULD is built for a 2–8 °C active container versus a passive pallet, and what dry ice UN1845 does to paperwork, ventilation and charge calculations. A 26-hour tarmac delay is the teaching case, so booking times are compared with the hours the product actually sat in ambient air.

What we cover

IATA TCR booking, labelling and the temperature service the airline actually sells
ULD build-up, active containers and passive pallets on the ramp
Dry ice UN1845: quantity, marks, ventilation and document checks that stop a pallet
Acceptance, transfer and the clock between warehouse and aircraft
Tarmac exposure, missing cool-dollies and what to write in a delay file
Handover to the receiving 3PL and logger stop at the destination ramp

Who it suits. Air cargo agents, forwarder operations staff and GDP warehouse leads who tender pharmaceutical freight at Changi.

Prerequisite. Familiarity with air waybills. Hazardous goods awareness for dry ice is useful; UN1845 is taught from public IATA language.

Assessment. Written paper (70%) plus a booking-and-acceptance checklist for a 2–8 °C pallet that includes a UN1845 charge.

Audience: freight forwarders, agents · Air

MDS-160

1 day · Group cap: 14

GDPMDS Essentials for Medical Device Distributors

MDS-160 reads publicly available HSA GDPMDS expectations for distributors who hold medical devices in Singapore, including those with labelled temperature limits. Participants separate device traceability, complaint and field-safety files from the medicine GDP vocabulary used next door, then apply mapping, monitoring and transport controls where the label demands 2–8 °C or a controlled room band. Storage of reagents, implants and equipment parts is treated as a condition-of-goods problem. The centre teaches the published requirements; it does not speak for the Authority and does not offer an inspection service.

What we cover

GDPMDS quality system, responsible person and documented storage conditions
Incoming inspection, lot traceability and quarantine of temperature-sensitive devices
Mapped storage and monitoring where the label states a temperature range
Transport, third-party warehouses and the controls a distributor still owns
Complaints, field safety and the temperature file that must sit with the event
Internal audit points that typically catch unmapped fridges and borrowed loggers

Who it suits. Distributor QA, warehouse leads and operations managers who hold medical devices with labelled temperature limits.

Prerequisite. Knowledge of the firm’s device list and current storage rooms. GDP-101 is optional context.

Assessment. Written paper (70%) plus a gap list against a sample GDPMDS warehouse description.

Audience: medical device distributors · Storage

CTS-170

1 day · Group cap: 14

Cold Chain for Clinical Trial Supplies and IMP Returns

CTS-170 follows an investigational medicinal product from depot release through site delivery, storage in a clinic fridge, and return or destruction. Participants practise pack-out against a protocol temperature range, site-readiness questions for a mapped fridge, and the extra records blinding and expiry impose on a logger file. Returns are treated as a controlled reverse lane, not leftover boxes. Excursions at the site are written so the sponsor file can show quarantine, notification and the decision that followed. Singapore import timing and weekend site closures are built into the lane examples.

What we cover

Protocol temperature range versus commercial labelled storage
Depot release, comparator handling and blinded pack identity
Site fridge mapping, daily checks and what a monitor may ask to see
Outbound qualification, courier hand-offs and weekend holding rules
IMP returns, unused stock, destruction records and temperature files
Excursion notification to sponsor QA and the language of a site deviation

Who it suits. Clinical supplies coordinators, depot staff and QA supporting trials that move IMPs through Singapore.

Prerequisite. Basic GDP or GCP warehouse exposure. Ability to read a protocol storage statement.

Assessment. Written paper (70%) plus an IMP return file with an excursion at a site fridge.

Audience: clinical supplies · Clinical

AUD-220

2 days · Group cap: 14

Internal Audit of Temperature-Controlled Warehouses

AUD-220 trains people who already work in GDP or GDPMDS environments to audit a temperature-controlled store. Participants build a trail: current mapping report, probe positions versus the floor plan, calibration of routine monitors, alarm tests, after-hours response, and a sample of logger files from inbound lanes. Interview questions are practised on packing, receiving and the person who silences the panel at 03:40. Findings describe product risk. Two days allow a mock audit cycle including close-out language.

What we cover

Audit planning against PIC/S GDP and the site’s own SOPs and mapping report
Sampling of logger files, calibration certificates and alarm-test records
Warehouse walk: airflow, door seals, staging and unmapped domestic fridges
Interview technique with store, engineering and the on-call roster
Grading findings by product risk and recurrence rather than by volume of paper
Report, CAPA quality and verification that a mapping gap was actually closed

Who it suits. Internal auditors, QA managers and responsible persons who must schedule and report warehouse audits.

Prerequisite. GDP-101 or MAP-210 recommended. Participants should have seen at least one mapping report from their own site.

Assessment. Written paper (70%) plus an audit observation write-up from a supplied warehouse file and floor plan.

Audience: internal auditors · Audit

CRY-180

1 day · Group cap: 14

Cryogenic and Ultra-Low Handling Awareness (LN2, −80 °C)

CRY-180 is an awareness day for people who receive, store or dispatch materials at −80 °C or in liquid-nitrogen dry shippers. Participants cover freezer mapping at ultra-low temperatures, alarm bands that fail if the probe sits in the neck, and the oxygen-depletion controls that sit beside GDP language. Dry-shipper charge, hold time and orientation are practised as a pack-out. Chain-of-identity for cell and gene materials is tied to the temperature file so a logger gap is treated as a product event.

What we cover

−80 °C freezer mapping, probe placement and alarm delay that still alerts someone
LN2 dry shippers: charge, hold time, orientation and receiving inspection
Oxygen depletion, ventilation and what a warehouse team may and may not do
Ultra-low pack-out, courier constraints and weekend hold rules
Identity, labelling and the temperature file for cell and gene shipments
Excursion language when a freezer warms through −60 °C or a dry shipper vents early

Who it suits. Warehouse and QA staff supporting cell and gene or laboratory materials, and 3PL teams newly asked to hold −80 °C stock.

Prerequisite. Site induction for LN2 if participants will later handle nitrogen on the floor. GDP-101 useful for the quality-system frame.

Assessment. Written paper (70%) plus a receiving checklist for a dry shipper and a −80 °C freezer alarm scenario.

Audience: cell & gene, laboratories · Clinical

Standards we reference in class

Classroom materials quote publicly available requirements so participants can find the same clauses after they leave. We work from the PIC/S GDP Guide, WHO annexes on temperature control of medicines, the IATA Temperature Control Regulations for air cargo language, USP general chapters that address distribution of drug products, and HSA GDPMDS guidance for medical device distributors in Singapore. Sglearninghubplus teaches against those published texts. We do not inspect, certify or speak for any authority, and attendance does not replace a firm’s own regulatory relationship.

What a certificate means

Certificates of completion are issued by Sglearninghubplus after the written paper and the practical are passed. They record training attendance and assessment for the named course code. They are not a licence, accreditation or regulatory approval, and they do not state that a warehouse, airline process or distributor system is qualified.

Match a code to your 2026 intake

If the labelled range, the lane or the audit calendar is already on your desk, send the details and we will point to one or two codes rather than the whole list.

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