CDMOs
Contract manufacturers serving multiple sponsors and markets, where every client audit tests your training file.
Manufacturing & distribution · Academy Layers 1 & 2
CPD-accredited Academy modules
The CPD Certification Service
cGMP and eQMS training built for CDMOs and API manufacturers
CPD-accredited, role-assignable courses that give every operator, analyst, QA officer and warehouse colleague the same inspection-ready baseline, with training records that sit inside the same validated quality system as your batches.
CPD-accredited Academy modulesThe CPD Certification Service
Aligned toUS FDAEU EMAUK MHRAIndia CDSCOChina
NMPAJapan PMDAPIC/SISO 9001 · 13485 · 27001
Who it's for
Every part of the manufacturing supply chain
One competence standard, from the dispensary to the distribution centre. Curricula are assigned by job function and tailored to your organisation chart during onboarding.
API & drug substance
Active ingredient and intermediate manufacturers working to ICH Q7 and Schedule M.
Finished dose
Small-molecule oral solids, liquids and sterile finished products under EU GMP Annex 1.
Distributors & wholesalers
GDP-regulated storage and distribution operators, including responsible-person and cold-chain teams.
Programme architecture
Four registers, one controlled index
Every course carries a permanent unique reference that never changes. Content changes move the version number, and every version is logged against a change control record in the TriQ™ eQMS.
Layer 1 · Released
Foundation cGMP
15 modules
Baseline GMP competence for all manufacturing and warehouse staff. 30–60 minutes each, mobile-friendly.
FND
Layer 1 · Roadmap
Advanced & specialist
14 entries
Role-based advanced pathways, specialist packs, ISO certification and localised editions on a quarterly release cycle.
ADVSPCISOLOC
Layer 2 · Released
Platform core
5 courses
Navigation, access control, e-records and e-signatures, audit-trail review, GAMP 5 and system administration.
SYS
Layer 2 · Released
eQMS modules
18 courses
One user-training course per licensed TriQ™ module, issued only where that module is deployed.
QMS
Reference format
YCO-ACA-L1-FND-003 v1.0Organisation ·
Academy · Layer · Pathway · Serial · Version
Role finder
See the curriculum for each job function
Taken directly from the Role Assignment Matrix, the provisioning source an inspector is shown against EU GMP Chapter 2, 21 CFR 211.25, Schedule M and ISO 9001 clause 7.2.
Master course index
The full course catalogue
Every course with its reference, scope, duration, CPD value, delivery mode, assessment method and regulatory anchor.
Development roadmap
A published quarterly release cycle
Subscribers receive new modules within their tier at no additional licence cost; specialist packs are add-ons. Roadmap dates are indicative and confirmed at contracting.
Regulatory coverage
One product, six regulators
Content is built to the most stringent applicable requirement, then localised where a market expects something specific.
| Authority | Region | What the training evidences |
|---|---|---|
| US FDA | United States | 21 CFR 210/211 and Part 11; ICH Q7 for API; data integrity guidance; pre-approval inspection readiness. |
| EU EMA | European Union | EU GMP Parts I–II, Annex 1, Annex 11 and Annex 15; QP certification; EudraGMDP expectations. |
| UK MHRA | United Kingdom | UK GMP; GxP data integrity and PQS; RP and QP disposition; MHRA inspection expectations. |
| India CDSCO | India (DCGI) | Revised Schedule M GMP; CDSCO inspection; state licensing alignment; Schedule M Annexure training records. |
| China NMPA | China | NMPA GMP and CDE expectations; PIPL data-handling controls. |
| Japan PMDA | Japan | PMDA / MHLW GMP ministerial ordinance; PIC/S-aligned inspection. |
Standards applied by default: ICH Q7 · Q8(R2) · Q9(R1) · Q10 · Q11 · Q12 · GAMP 5 (2nd ed.) · 21 CFR Part 11 · EU Annex 11 · PIC/S PE 009 · ISO 9001:2015 · ISO 13485:2016 · ISO 14971:2019 · ISO/IEC 27001:2022 · ISO 19011:2018
Inspection-ready by design
Every assignment produces evidence
Training, CPD and the quality system share one audit trail, so nothing is stitched together at inspection time.
Training record per learner
Assessment result, read-and-acknowledge and an exportable training file for every course completed.
Individual CPD certificate
Learner name, module, CPD value, date and a unique verification reference, issued on pass.
Employer CPD dashboard
Completion, expiry and CPD accrual by department, role and individual, exportable for management review.
Controlled content
Authored to a content specification, SME-reviewed, CPD-submitted and version-controlled in the TriQ™ eQMS.
Indicative pricing 2026
Transparent, tiered, in your currency
Layer 1 is priced per learner per year. Layer 2 is an annual subscription per site.
Layer 1 — Foundation cGMP training
Per learner per year, CPD-accredited. Volume tier applies to all learners.
Included in every subscription
- Hosting, backup and disaster recovery — single-tenant option, encrypted at rest and in transit, 25-year retention.
- Regulatory-change updates — content and configuration kept current with GMP, GDP and ISO changes.
- Named customer success lead — one Yoshe contact and a quarterly service review.
- Inspection support — remote support and live evidence retrieval during inspections and certification audits.
Estimate your Layer 1 investment
Enter your headcount for an indicative annual figure.
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One-time implementation
Indicative list pricing from the TriQ™ CDMO Commercial Service Brochure 2026 (YCO-BRO-2026-TriQ-CDMO-002), for planning only. Excludes local taxes (GST / VAT). Currency figures use planning FX of USD 1 = INR 87 = EUR 0.92 = CNY 7.25 and are rounded. Multi-site, multi-year, multi-layer and volume agreements attract discount. A formal quotation is issued on scoping.
One academy across the product lifecycle
From the clinic to the manufacturing floor
The CDMO cGMP Programme extends the same Yoshe Clinical Academy standard used by clinical research sites, CROs and pharma and biotech sponsors.
Clinical development
Sites, CROs and sponsors
- ICH E6(R3) GCP and role-based clinical research training
- Therapeutic area training added when staff join a study
- Career pathways from Principal Investigator to CRA to PV Manager
Manufacturing & supply · You are here
CDMOs, API, finished dose and GDP
- 15 released foundation cGMP modules, CPD-accredited
- 23 eQMS courses tied to the TriQ™ modules you license
- Bespoke modules authored from your own batch records (Layer 3)
Book a scoping call
Tell us about your site, products and target markets. We'll reply by email with a tailored course and CPD map and a formal quotation.
Quality system enquiries: [email protected]
- Gap analysisAgainst your target markets, product types and ISO certification scope.
- Course and CPD mapMandatory and recommended courses for each job function on your organisation chart.
- QuotationLayer 1, Layer 2 and any Layer 3 bespoke modules, in your currency.