Pharmaceutical Serialisation and Track-&-Trace Compliance Corporate Training
Build end-to-end serialization and track-and-trace compliance with guided EPCIS and aggregation labs.
Edstellar, a corporate training company, delivers instructor-led serialization training that helps pharmaceutical packaging, warehouse, quality, and IT teams implement unit-level coding, EPCIS event capture, aggregation hierarchies, and compliant data exchange with trading partners across regulated markets.
Instructor-led group trainingVirtual / on-site / off-site10 languagesDelivered inEnglish, Spanish, Mandarin, German, Arabic, Portuguese, Hindi, French, Japanese, Italian100+ countriesWe have delivered inUnited States, United Kingdom, India, Canada, Germany, France, Netherlands, UAE, Saudi Arabia, Singapore, Australia, Japan, Brazil, South Africa and 90+ more countries
How we build a serialization-ready supply chain team
The Edstellar PHARMACEUTICAL SERIALISATION & SUPPLY CHAIN Capability Model
Diagnose serialization maturity
Map current packaging lines, master data, and event capture against DSCSA, EU FMD, and target-market serialization mandates.
Standardize identifiers and events
Align GTIN, serial numbers, SSCCs, and EPCIS event types so every pack, case, and pallet speaks one data language.
Practice in guided labs
Model commissioning, aggregation, shipping, and exception events in sandbox EPCIS flows before touching live lines.
Measure compliance readiness
Verify event completeness, aggregation accuracy, and audit-trail integrity against regulator expectations.
Scale across lines and markets
Extend validated serialization and reporting patterns to new packaging lines, partners, and country regulations.
Need more than one program?Get a group quote
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Program Overview: What is Pharmaceutical Serialisation and Track-&-Trace Compliance?
Pharmaceutical Serialisation & Track-&-Trace Compliance is Edstellar's instructor-led program for pharma operations and quality teams implementing serialisation. Participants cover the global regulatory landscape, GTIN and GS1 identification standards, EPCIS event modeling, aggregation hierarchies, repositories and master data, and exception management. The focus stays on traceability that passes inspection.
Across 28 hours, participants model EPCIS events for commissioning, shipping, and receiving, build aggregation hierarchies with parent-child relationships, and practice trading-partner data exchange in guided exercises with instructor review. Exception management drills cover suspect product scenarios, and inspection readiness modules walk through what regulators actually ask. The program closes with an end-to-end track-and-trace implementation.
Serialisation projects fail at the handoffs: aggregation breaks, master data drifts, and suspect product workflows exist only on paper. This program teaches teams to build traceability as a working system, not a checkbox, with event modeling and exception handling that hold up in live operations. Compliance survives the audit.
The closing implementation exercise has the team stand up an end-to-end track-and-trace flow: serializing product, building aggregation, modeling the EPCIS events across a ship-and-receive cycle, and resolving a suspect product exception. Building it working is what makes the difference, because the exceptions they handle in the lab are the ones that will happen at 6 p.m. on a Friday.
Serialization failures trigger quarantines, delayed releases, and regulatory findings. This program gives packaging engineers, warehouse leads, quality assurance, and IT staff a working command of GS1 identifiers, 2D data carriers, commissioning and aggregation logic, EPCIS repositories, and suspect-product investigations. Labs use realistic pack, case, and pallet scenarios so teams return able to keep lines compliant, exchanges accurate, and audit trails inspection-ready.
What's Included in this Workshop for Your Enterprise Teams
- 1
Regulatory and standards foundations
DSCSA, EU FMD, GS1 identifiers, and country-specific serialization mandates.
- 2
EPCIS event modeling labs
Commissioning, aggregation, shipping, and decommissioning event practice.
- 3
Aggregation and exception workshops
Parent-child hierarchies, inferencing rules, and suspect-product flows.
- 4
Repository and exchange integration
Master data, repository architecture, and trading-partner data exchange.
- 5
Inspection readiness drills
Audit-trail reviews, mock inspections, and compliance evidence packs.
- Instructor-led sessions across virtual, onsite, or hybrid formats
- Guided serialization and EPCIS labs in sandbox environments
- Course materials with identifier standards and event templates
- Hands-on exercises using realistic pack, case, and pallet data
- Assessment of serialization workflows and exception handling
- Post-training support for implementation questions
Build your team's skills. Anywhere in the world.
Real-world use cases
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for your teams
Delivered globally
in 100+ countries
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Pharmaceutical Serialisation and Track-&-Trace Compliance Course Topics and Program Outline
A 28-hour instructor-led program covering serialization standards, EPCIS event modeling, aggregation, repository architecture, trading-partner exchange, exception management, and inspection readiness, with guided labs in every module.
Built by Edstellar with pharmaceutical serialization practitioners
Built by serialization consultants and packaging systems practitioners who implement track-and-trace programs in production, shaped around your stack and use cases.
We map your lines, master data, and event capture against DSCSA, EU FMD, and your target markets before day one.
Master identifiers, data carriers, and global regulations with instructor demos drawn from real packaging lines.
Model EPCIS events, aggregation hierarchies, and partner exchanges in sandboxes that mirror live operations.
Close with a capstone blueprint for your products, partners, and markets, reviewed by the instructor.
Leave with a validated serialization blueprint for your packaging lines and trading partners.
Delivered as
Delivery is instructor-led and hybrid-ready. Lab scenarios adapt to your packaging lines, warehouse systems, and target markets.
Map a sample product portfolio against the mandates of three target markets.
learna)Drivers of serialization: counterfeits, recalls, and patient safety
b)DSCSA requirements: product identifiers, transaction data, and verification
c)EU Falsified Medicines Directive: safety features and repository model
d)National mandates: India, Brazil, Turkey, and other market timelines
e)Roles and responsibilities across MAH, CMO, 3PL, and wholesaler
Generate and grade sample GS1 DataMatrix codes for unit and case levels.
learna)GTIN structure, serial numbers, lot, and expiry encoding
b)SSCC for logistic units: cases, pallets, and shipments
c)GS1 DataMatrix, QR, linear barcodes, and RFID trade-offs
d)Print quality, grading, and verification standards
e)Commissioning logic: assigning serial numbers at the line
Author EPCIS events for a commission-pack-ship sequence in a sandbox repository.
practicea)EPCIS event types: ObjectEvent, AggregationEvent, TransactionEvent
b)Commissioning and packing events at the packaging line
c)Shipping, receiving, and transformation events
d)Business step and disposition semantics
e)Event completeness checks and error handling
Construct and validate aggregation hierarchies, then resolve induced breaks.
practicea)Aggregation models: unit, case, pallet hierarchies
b)Parent-child inference and its regulatory limits
c)Partial aggregation, rework, and de-aggregation scenarios
d)Aggregation capture on packaging lines and in warehouses
e)Reconciling hierarchy breaks during shipping and receiving
Configure a repository flow and exchange EPCIS data between simulated partners.
practicea)Level 1-4 repository architecture and responsibilities
b)Master data: product, location, and partner identifiers
c)EPCIS query interfaces and data-sharing agreements
d)DSCSA transaction information and statements
e)Onboarding CMOs, 3PLs, and wholesalers to serialization feeds
Run a suspect-product investigation and assemble the audit evidence pack.
applya)Exception types: unreadable codes, duplicate serials, hierarchy breaks
b)Suspect and illegitimate product investigation workflows
c)Quarantine, notification, and disposition procedures
d)Audit-trail design: immutability and retention
e)Mock inspections and compliance evidence packs
Build and present a full serialization blueprint for instructor review and feedback.
applya)Line-level serialization and vision-system integration plan
b)End-to-end EPCIS event and aggregation design
c)Repository architecture and partner exchange blueprint
d)Exception and recall readiness procedures
e)Regulatory submission and inspection readiness checklist
Customize this program tailored to your team?
Tell us your training needs: what your team already works with, the level they’re at, and the topics you want them to focus on. We’ll adjust the modules, duration and hands-on labs, and send you a customized outline for your group.
Key Skills and Outcomes Your Team Will Gain
By the end of this program, your team will operate serialization and track-and-trace systems with confidence across packaging lines, warehouses, and partner exchanges.
Apply global serialization mandates
Interpret DSCSA, EU FMD, and national requirements and translate them into packaging and distribution actions.
Encode GS1 identifiers correctly
Assign GTINs, serial numbers, and SSCCs and verify DataMatrix and barcode quality on the line.
Model EPCIS events
Author commissioning, aggregation, shipping, and receiving events that capture complete supply-chain history.
Build aggregation hierarchies
Construct parent-child relationships and apply inferencing rules that survive audits and partner checks.
Operate serialization repositories
Manage master data, repository flows, and secure data exchange with CMOs, 3PLs, and wholesalers.
Manage exceptions and suspect product
Investigate unreadable codes, duplicate serials, and hierarchy breaks under quarantine procedures.
Pass regulatory inspections
Assemble audit trails and evidence packs that demonstrate serialization compliance to inspectors.
Teams that Benefit from this Pharmaceutical Serialisation and Track-&-Trace Compliance Group Training
This program is built for pharmaceutical packaging, warehouse, quality, regulatory, and IT teams that own serialization and track-and-trace operations. Content adapts to each cohort's lines, systems, and markets so every team practices the workflows it owns.
Keep serialization lines running and compliant
Engineers learn commissioning logic, vision-system integration, and print verification so packaging lines produce compliant serialized units at speed.
Workflow friction
- Unreadable codes causing rework
- Serial number collisions across lines
- Slow aggregation capture
How the program helps
- Commission units accurately at line speed
- Verify DataMatrix print quality consistently
- Reduce line stops from code errors
Practice use cases
- line commissioning labs
- print verification drills
- aggregation capture
Prove compliance with inspection-ready evidence
QA and regulatory staff learn audit-trail design, exception workflows, and mock inspections so every audit finds complete, defensible records.
Workflow friction
- Incomplete event histories
- Weak quarantine documentation
- Inconsistent partner data
How the program helps
- Build audit trails inspectors trust
- Investigate suspect product correctly
- Assemble evidence packs faster
Practice use cases
- mock inspections
- evidence pack assembly
- quarantine workflows
Move serialized product without breaking compliance
Warehouse and distribution teams learn receiving, shipping, and aggregation reconciliation so product flows stay traceable end to end.
Workflow friction
- Hierarchy breaks in transit
- Missing partner event data
- Return serialization gaps
How the program helps
- Reconcile hierarchies on receipt
- Ship with accurate EPCIS events
- Handle returns compliantly
Practice use cases
- receiving reconciliation
- shipping event labs
- returns handling
Run the repositories and exchanges serialization needs
IT teams learn repository architecture, master data governance, and EPCIS exchange so serialization data flows reliably to every partner.
Workflow friction
- Fragmented master data
- Unreliable partner feeds
- Repository scaling issues
How the program helps
- Architect reliable repository flows
- Govern master data centrally
- Exchange EPCIS data securely
Practice use cases
- repository configuration
- EPCIS exchange labs
- master data governance
Cohorts can mix functions or focus on one; labs adapt to your packaging equipment, WMS, and repository stack.
Prerequisites: Participants benefit most from familiarity with pharmaceutical packaging, warehouse, or supply-chain operations. No prior serialization or EPCIS experience is required; the program builds from identifiers and mandates up to repository architecture. Content adapts to each cohort's systems, partners, and target markets.
Line Operator to Serialization Program Lead
The program moves from mandates and identifiers through EPCIS modeling and repositories to inspection readiness and implementation leadership.
One program that grows with serialization careers, from line basics to enterprise track-and-trace ownership.
Mixed cohort, or several teams at once?
We can tailor the training to different teams, roles, and experience levels within the same program.
Certificate of Training Completion.
On successful completion, employees receive an Edstellar course completion certificate, recognizing their commitment to ongoing learning and professional development. It validates the skills they have built and motivates them to keep growing and contribute to organizational success.
Earned, not attended. Awarded on completion of all hands-on labs and the capstone project.
Training Delivery Modes: Virtual, Onsite and Hybrid
Choose the format that fits your packaging sites and teams: fully virtual labs, onsite sessions at your facility, or a hybrid blend.
Hybrid Training
Blend virtual theory with onsite lab days at your packaging site, so teams learn standards remotely and practice on familiar equipment.
- Virtual sessions for regulations and standards
- Onsite labs aligned to your packaging lines
- One cohort, one consistent curriculum
- Recorded sessions for shift coverage
Onsite Training
Run the full program at your packaging or distribution facility, with labs mapped to your lines, scanners, and warehouse systems.
- Training at your packaging facility
- Labs using your line configurations
- Cross-shift team participation
- Direct coaching on your workflows
Live Virtual Training
Join live from any site with instructor-led sessions and cloud sandbox labs for EPCIS modeling and repository exercises.
- Live instructor-led virtual sessions
- Cloud sandboxes for EPCIS labs
- Breakout rooms for team exercises
- Digital materials and templates
Need a training format that works for your team?
Full days, half days across weeks, or split by module. Tell us the delivery window and we schedule the cohort around it.
Frequently Asked Questions
Share your team size, sites, and target markets through the request form and we will send a tailored proposal with schedule options.
Yes. A discovery call maps your lines, systems, and mandates so the program targets your serialization gaps.
Yes. Live virtual sessions include cloud sandbox labs for EPCIS modeling, aggregation, and repository exercises.
Yes. Onsite delivery maps labs to your packaging lines, scanners, and warehouse systems for direct relevance.
The program runs 28 instructor-led hours, typically over four days, with guided labs in every module.
Question not answered here?
Put it in the request. A training specialist answers it directly, within one business day.
Where this Training Fits in Your Team's learning path.
Serialisation sits after manufacturing and distribution practice because it adds identity to product that is already made and moved under control. Your team covers GMP and GDP first, then implements track-and-trace, and finally looks at how blockchain could extend supply chain traceability.
Why Choose Edstellar as Your Pharmaceutical Serialisation and Track-&-Trace Compliance Training Provider
Edstellar delivers serialization training shaped around your lines, warehouses, and regulatory markets, with labs that mirror real operations.
EXPERT TRAINERS
YEARS DELIVERING
ORGANIZATIONS TRAINED
CERTIFIED
Tailored
Curriculum adapts to your packaging lines, warehouse systems, target markets, and serialization maturity.
Proven Methodology
A learn-practice-apply arc moves teams from mandates to validated serialization blueprints.
Practice-Based Learning
Guided EPCIS, aggregation, and repository labs build muscle memory before live implementation.
Expert Trainers
Serialization consultants with production track-and-trace experience lead every session and lab.
Global Scale
We train packaging and supply-chain teams across sites, shifts, and regulated markets worldwide.
Measurable Outcomes
Readiness checks on event completeness and aggregation accuracy show compliance progress.
Connect Pharmaceutical Serialization Data With Traceable Product Movements and Exceptions
Edstellar guides operations and quality teams from product identifiers to complete track-and-trace workflows. Participants encode GS1 data, model EPCIS events, and validate aggregation across simulated partner exchanges. Repository exercises and suspect-product scenarios culminate in a serialization blueprint, reviewed for event consistency, traceability, and the evidence supporting exception resolution.
- Step 01
Consult
We review packaging and supply-chain experience, target-market scope, and difficulties with aggregation or partner data exchange to establish the cohort's serialization learning needs.
- Step 02
Plan
We introduce mandates and GS1 identifiers before EPCIS events, aggregation, repository flows, and master data, then integrate exception management into the implementation exercise.
- Step 03
Align
We align serialization and traceability expertise with packaging, warehouse, and quality roles, confirming the sandbox repository and simulated partner exchanges needed for practice.
- Step 04
Customize
We shape sample product hierarchies and shipping scenarios around familiar packaging levels and partner handoffs, using synthetic identifiers and deliberately introduced aggregation breaks.
- Step 05
Execute
Participants create EPCIS events, validate parent-child relationships, and investigate suspect-product exceptions, receiving feedback on event sequencing, master data consistency, and traceability evidence.
- Step 06
Evaluate
We review the serialization blueprint and simulated product journey for valid identifiers, coherent aggregation, complete event records, and a documented approach to exceptions.
Also from Edstellar
Talent assessments
Psychometric, behavioral, leadership and 360-degree assessment.
→Training needs analysis
Needs analysis, gap identification, and a training roadmap.
→L&D consulting
Learning strategy, content, technology and ROI measurement.
→OD consulting
Org design, succession planning and cultural change.
→Managed training services
Training outsourcing, vendor management, logistics and administration.
→Coaching solutions
Executive and manager coaching that keeps skills in use.
Start an RFP shaped to your needs.
Answer three quick questions about team size, scope, and how often you need the program run, then send the request from the last step. Everything you choose travels with it, so you only fill this in once.
How many team members need training?
Pharmaceutical Serialisation & Track-&-Trace Compliance Training Packages & Pricing
Where L&D holds an annual budget, license packages price the whole year at once instead of raising a purchase order per workshop. Hours and licenses are pooled across teams, programs and locations, so unused capacity is not stranded in one department.
Starter
120
trainee licenses64 hours of group training
Tailored for SMBs
Growth
320
trainee licenses160 hours of group training
Ideal for growing SMBs
Enterprise
800
trainee licenses400 hours of group training
Designed for large corporations
Custom
Unlimited
trainee licensesDuration set by the rollout
Multi-region and multi-year
Training Packages & Pricing
Choose the training format that works for your team. Pricing is customized based on your requirements, cohort size, and delivery needs.
Request Pharmaceutical Serialisation and Track-&-Trace Compliance Training for Your Team
Share your team size, packaging sites, target markets, and timelines to receive a tailored training proposal with schedule options.