Pharmaceutical Supply Chain Management Training Course

Duration 10 days 16 modules · 65 contact hours
Level Intermediate Certificate on completion
Who attends Pharmaceutical Supply Chain Managers, Quality Assurance Managers and others
Fee from USD 2,200 KSh 190,000 for Kenyan organisations
Where 52 cities + online See dates by city
Next start 9 Nov 2026 Course code SD-SCM-037

Before you join: Participants should have practical experience in pharmaceutical operations, procurement, warehousing, logistics, quality assurance or distribution planning.

Dates & prices

Two start dates a month in every city, and live online on weekdays or weekends. Fees are per participant; classroom fees include tuition, materials, lunch and refreshments, and the certificate.

Suggest a date or city

Showing the next six months. Later dates, other cities and private deliveries for your team are available on request.

Course overview

Pharmaceutical supply chains must protect product quality, patient safety and regulatory compliance from supplier release through final delivery. Temperature excursions, falsified medicines, weak chain-of-custody records, unauthorised distribution, shortages and recall delays can lead to rejected stock, market disruption, inspection findings and patient harm. Supply chain teams need controls that preserve product identity, condition and traceability while maintaining service levels and cost discipline.

This course develops practical capability in pharmaceutical supply chain security and quality-controlled distribution. Participants examine GDP requirements, product risk classification, supplier qualification, cold-chain design, serialisation, track-and-trace data, warehouse controls, transport qualification, deviation handling, recalls and business continuity. They use risk-based methods including FMEA and ICH Q9(R1) principles to identify failure modes, rank risks and define preventive controls. The programme also addresses controlled medicines, theft prevention, third-party logistics governance and response to suspected falsified products.

Teaching combines focused instructor briefings with pharmaceutical cases, group analysis, supply disruption simulations and structured application planning. Participants progressively build a supply chain security file for a realistic pharmaceutical product, beginning with its product profile and distribution map, then adding risk assessments, control measures, temperature-management arrangements, supplier controls and incident procedures. They leave with a reusable set of templates and a reviewed supply chain security plan suitable for adaptation within their organisation.

The course suits professionals who already work with pharmaceutical procurement, quality, logistics, warehousing, distribution or supply planning and now need stronger command of product-security and GDP-controlled supply chains.

What you will be able to do

  • Map pharmaceutical product, information and custody flows from release to patient delivery
  • Apply GDP requirements to storage, transport, documentation and outsourced distribution controls
  • Conduct an FMEA-based supply chain risk assessment for a pharmaceutical product
  • Design temperature-control arrangements using lane profiles, data loggers and excursion procedures
  • Evaluate suppliers and logistics providers using risk-based qualification and quality agreements
  • Implement serialisation, traceability and verification controls for regulated medicine distribution
  • Prepare deviation, recall and suspected falsified medicine response procedures
  • Present a complete pharmaceutical supply chain security plan with prioritised controls

Benefits of attending

For you

  • Ability to assess distribution risks before they become quality incidents
  • Confidence interpreting GDP controls during supplier and logistics provider reviews
  • Practical methods for investigating temperature excursions and custody failures
  • A defensible approach to traceability, recall readiness and falsified medicine response
  • A completed security plan that can support workplace improvement proposals

For your organisation

  • Fewer product-quality failures during storage, transport and outsourced distribution
  • Improved readiness for GDP inspections, audits and customer quality assessments
  • Clearer accountability between quality, procurement, warehousing and transport providers
  • Stronger prevention and escalation controls for theft, diversion and falsified medicines
  • Faster, better-documented responses to excursions, shortages and product recalls

Course modules

16 modules over 10 days

Participants can define the quality, security and continuity controls required across a pharmaceutical supply chain.

  • Pharmaceutical supply chain stages from API sourcing through patient delivery
  • Product identity, strength, quality and custody preservation requirements
  • GDP, GMP and pharmacovigilance interfaces within distribution operations
  • Patient safety consequences of diversion, theft and falsified medicines
  • Quality unit responsibilities for release, distribution oversight and escalation
  • Supply chain security governance, accountability matrices and control ownership

Participants can create a product profile that determines proportionate distribution controls.

  • Product criticality classification using temperature, value and patient-impact criteria
  • Define shelf-life, storage range and handling restrictions by product
  • Batch, expiry and serial-number data requirements for each movement
  • Route profiles covering origin, destination, handovers and transit duration
  • Identify special controls for biologics, vaccines and controlled medicines
  • Distribution profile assumptions documented for quality approval and review

Participants can translate GDP expectations into controlled distribution processes and records.

  • WHO GDP principles for premises, personnel, documentation and transportation
  • Standard operating procedures controlling receipt, storage and dispatch activities
  • Document control, training records and contemporaneous data-entry expectations
  • Change control for routes, carriers, packaging and storage conditions
  • Deviation, CAPA and effectiveness-check links within the quality system
  • Self-inspection schedules focused on high-risk distribution controls

Participants can map physical and information flows to identify custody and visibility gaps.

  • Swimlane mapping for material, data and ownership handovers
  • Map legal title, physical custody and quality responsibility separately
  • Chain-of-custody records at warehouse, carrier and consignee handovers
  • Identify blind spots between distributors, brokers and third-party logistics providers
  • Reconciliation controls for quantities, batches, serials and delivery evidence
  • Escalation paths for missing product, damaged seals and delayed deliveries

Participants can perform and document an FMEA-based distribution risk assessment.

  • ICH Q9(R1) principles for risk-based quality decisions
  • FMEA scoring for severity, occurrence, detectability and risk priority
  • Failure modes affecting temperature, identity, security and availability
  • Root-cause categories using fishbone analysis for distribution failures
  • Control selection based on risk ranking and residual risk
  • Risk-register ownership, review triggers and management escalation thresholds

Participants can qualify suppliers and logistics providers using documented risk-based criteria.

  • Supplier segmentation by material criticality, spend and quality risk
  • Prequalification evidence including licences, GDP status and quality history
  • Audit plans matched to product risk and provider responsibilities
  • Quality agreements defining deviations, change notification and record retention
  • Carrier qualification using route capability, security and temperature evidence
  • Performance scorecards covering OTIF, excursions, CAPA and complaint trends

Participants can establish warehouse controls that preserve product condition, status and traceability.

  • Status segregation for released, quarantined, returned and recalled stock
  • FEFO rules supported by batch, expiry and inventory-system controls
  • Temperature mapping principles for warehouses, chambers and loading areas
  • Environmental monitoring alarms, alert limits and response responsibilities
  • Physical security zones, access control and visitor management records
  • Cycle counting and reconciliation methods preventing stock discrepancies

Participants can design temperature-controlled distribution controls and manage excursion decisions.

  • Lane qualification using seasonal profiles, duration data and risk scenarios
  • Packaging selection based on payload, ambient exposure and route duration
  • Data logger placement, calibration status and retrieval procedures
  • Temperature excursion triage using product stability and exposure evidence
  • Mean kinetic temperature limitations for temperature-sensitive pharmaceutical products
  • Disposition decisions documented by quality, technical and supply stakeholders

Participants can select transport security controls appropriate to product and route risk.

  • Threat assessment for theft, hijacking, diversion and tampering
  • Route risk profiling using crime exposure, border crossings and stops
  • Seal management, tamper-evident packaging and vehicle-security inspection checks
  • Carrier security requirements for secure parking and driver communications
  • GPS monitoring, geofencing and escalation for route deviations
  • Incident preservation procedures for evidence, insurers and regulatory authorities

Participants can specify traceability controls for serialised products and regulated distribution channels.

  • Unique identifier elements: product code, serial, batch and expiry
  • Aggregation relationships between packs, cases, pallets and shipments
  • Verification workflows for dispensing, returns, decommissioning and rework
  • DSCSA transaction data concepts for United States prescription medicines
  • European Falsified Medicines Directive verification and alert handling
  • Master data governance for product identifiers and trading partners

Participants can identify suspicious products and manage returns without compromising supply integrity.

  • Indicators of falsified medicines in packaging, documentation and serial data
  • Quarantine procedures for suspected falsified, tampered or diverted products
  • Investigation workflows involving quality, security, regulatory and legal teams
  • Authorised returns criteria, inspection records and resale decisions
  • Reverse logistics controls preventing re-entry of unsuitable products
  • Reporting routes to regulators, marketing authorisation holders and partners

Participants can prepare continuity measures for supply disruptions affecting critical products.

  • Demand sensing inputs from orders, epidemiology, tenders and consumption
  • Safety-stock policies based on demand variability and replenishment risk
  • Shortage risk indicators for suppliers, capacity and transport lanes
  • Business continuity plans for site closures, port delays and recalls
  • Alternative source qualification before disruption-driven purchasing decisions
  • Allocation rules balancing patient need, contracts and regulatory commitments

Participants can investigate distribution incidents and define effective corrective and preventive actions.

  • Deviation classification by patient impact, product risk and recurrence
  • Containment actions for delayed, damaged or temperature-exposed shipments
  • Five Whys and fishbone analysis for incident root causes
  • CAPA plans with owners, due dates and effectiveness measures
  • Customer complaints linked to distribution records and batch traceability
  • Trend analysis for recurring excursions, losses and provider failures

Participants can prepare a recall response structure supported by traceable distribution data.

  • Recall classification based on patient risk and regulatory requirements
  • Distribution trace exercises using batch, consignee and shipment records
  • Recall decision roles within quality, regulatory, legal and supply teams
  • Customer notification content, acknowledgement tracking and stock reconciliation
  • Mock recall performance measures for speed, completeness and accuracy
  • Crisis communications controls for authorities, customers and internal leadership

Participants can monitor distribution control performance and prepare evidence for inspection.

  • KPI hierarchy for quality, service, security and cost performance
  • Leading indicators for excursions, overdue CAPA and training compliance
  • Management review packs linking trends to risk decisions
  • Inspection evidence files for providers, routes and temperature controls
  • Audit interview preparation using process ownership and document trails
  • Continuous improvement priorities derived from recurring control weaknesses

Participants can build, review and present a complete pharmaceutical supply chain security plan for a defined product and distribution route.

  • Product profile, distribution map and critical control points consolidated
  • FMEA risk register with ranked threats and assigned controls
  • GDP control matrix covering warehouse, transport and provider responsibilities
  • Temperature-management plan including qualification, monitoring and excursion decisions
  • Traceability, security, recall and continuity procedures integrated
  • Peer review against inspection evidence, feasibility and patient-risk criteria

Exercises and examples are adapted to each cohort's sectors and roles.

What you take back to work

  1. Pharmaceutical supply chain security plan template
  2. FMEA distribution risk register
  3. GDP provider qualification checklist
  4. Temperature excursion assessment form
  5. Traceability and recall readiness model
  6. Distribution KPI and audit evidence pack

Who should attend

  • Pharmaceutical Supply Chain Managers — need end-to-end controls for quality-assured product movement
  • Quality Assurance Managers — oversee GDP compliance, deviations and distribution provider governance
  • Procurement Managers — qualify suppliers and protect continuity for critical medicines
  • Logistics and Distribution Managers — manage storage, transport and chain-of-custody controls
  • Warehouse Managers — maintain compliant inventory, security, segregation and environmental monitoring
  • Regulatory Affairs Professionals — support distribution compliance, traceability and inspection readiness

Skills and tools covered

GDP complianceCold-chain managementSupply risk assessmentPharmaceutical traceabilitySupplier qualificationRecall preparedness

Tools and standards

ICH Q9(R1) Quality Risk Management, WHO Good Distribution Practices for Pharmaceutical Products, USP <1079> Good Storage and Distribution Practices, Failure Mode and Effects Analysis (FMEA)

How the course runs

Training methodology

The course uses short instructor briefings to introduce standards, controls and decision methods, followed by pharmaceutical cases drawn from distribution, cold-chain and security incidents. Participants work in groups to map product flows, assess risks, review provider evidence and make response decisions during simulated disruptions. Templates are completed in stages so that each method is applied to a realistic product and distribution route. Facilitated peer review tests assumptions, identifies control gaps and strengthens individual application plans.

Requirements and prerequisites

Participants should have practical experience in pharmaceutical operations, procurement, warehousing, logistics, quality assurance or distribution planning. They should understand basic supply chain terms such as lead time, inventory, supplier, warehouse, transport provider and batch number. Familiarity with GMP, GDP or pharmaceutical quality systems is useful but not essential; relevant requirements are introduced during the course. This is not an introductory logistics programme, and it does not require prior statistical training, specialist software skills, legal qualifications or previous experience of serialisation systems.

A typical training day

08:30 – 10:30First session
10:30 – 10:45Refreshment break
10:45 – 12:30Second session
12:30 – 13:30Lunch and networking
13:30 – 15:00Third session
15:00 – 15:15Refreshment break
15:15 – 16:30Workshop and daily review

Live online deliveries follow the same structure in East Africa Time, with shorter screen blocks and longer breaks.

What the fee includes

  • Instruction by a practitioner facilitator
  • Full course workbook and materials
  • Exercise files, templates and case studies
  • Refreshments and lunch on classroom deliveries
  • Certificate of completion
  • Post-course application plan

Frequently asked questions

You should have working familiarity with pharmaceutical operations, procurement, quality, warehousing or logistics. Prior GDP knowledge is helpful but not required, as the course introduces the relevant controls and terminology.

Bring a laptop if possible, plus a non-confidential example of a product, route, distribution issue or provider arrangement from your work. Participants can also use the supplied pharmaceutical case if workplace materials cannot be shared.

It is designed for professionals responsible for pharmaceutical supply, quality assurance, procurement, warehousing, transport, distribution or regulatory support. It is particularly useful where products are temperature-sensitive, high-value, controlled or distributed through third parties.

General supply chain courses focus primarily on planning, inventory, sourcing and logistics efficiency. This course concentrates on pharmaceutical product quality, GDP, chain of custody, temperature control, traceability, falsified medicines and recall readiness.

You will use the templates to review a product route, assess risks, evaluate provider controls and improve incident or recall procedures. The final security plan can form the basis of a workplace improvement proposal.

Each training day runs from 08:30 to 16:30 and provides about 6.5 contact hours. Early modules establish product, GDP and risk controls; later modules address cold chain, traceability, incidents, recalls and the final plan presentation.

Questions about this course?

Ask about dates, fees, group bookings or running it for your team. Our training team replies by email.

Ask on WhatsApp info@skillsetdevelopment.com

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