Description

A focused course, tailored for you

Building Modern Life Sciences Supplier Quality Programme (ISO 13485 + GMP + IVDR + FDA QSR + Supplier Onboarding + Audit + AI Quality + Multi-Country)

Build the modern life sciences supplier quality programme in 10 weeks. ISO 13485 + GMP + IVDR + FDA QSR + supplier onboarding + audit + AI quality + multi-country.

Life sciences supplier quality leaders at lab-services + medical-device + pharma firms face complex multi-jurisdiction supplier-quality requirements: ISO 13485 supplier management, GMP supplier qualification, IVDR/MDR supplier obligations, FDA QSR alignment effective February 2026, supplier-onboarding modernisation, AI quality in supplier oversight, and engagement economics. Leaders who build the modern programme take the senior quality work. Here is the 10-week build.

$199 one-time

Tailored to your situation. Access within 24 hours. 30-day money-back.

Includes a hand-built implementation playbook delivered alongside course access, generated for your specific situation.

Why this course

Life sciences supplier quality leaders (at LGC Group, Eurofins, Charles River Laboratories, IQVIA, Labcorp, Quest Diagnostics, Sotera Health Nelson Labs, BioReliance, WuXi AppTec, WuXi Biologics, Lonza, Catalent, Recipharm, Patheon Thermo Fisher, AGC Biologics, Boehringer Ingelheim BioXcellence, Cambrex, CordenPharma, Curia, Evonik, FUJIFILM Diosynth Biotechnologies, Hovione, Olon, PCI Pharma Services, Piramal Pharma Solutions, Samsung Biologics, Siegfried, Wuhan Biolake, Sinopharm, China Resources Pharmaceutical, Tianjin Tasly, Hengrui Medicine, BeOne Medicines BeiGene, Innovent Biologics, Junshi Biosciences, Aerogen, Apheris, MeMed, Owl Insights, Cerba HealthCare, Synlab International, Unilabs, Synevo Romania, AML Medical Laboratory, MML Medical Lab, Mayo Medical Lab, ACL Laboratories, Sonic Healthcare, ResMed, Becton Dickinson, Abbott, Roche Diagnostics, Siemens Healthineers, Danaher Diagnostics, Hologic, Mindray, Sysmex, Bio-Rad, PerkinElmer Diagnostics, Ortho Clinical Diagnostics, Werfen Instrumentation Laboratory) face complex multi-jurisdiction supplier-quality requirements in 2024-2026.

ISO 13485:2016 supplier management (clause 7.4 purchasing process, supplier evaluation framework, supplier-controls framework, supplier-monitoring framework), GMP supplier qualification (FDA 21 CFR 211, EU GMP, PIC/S, WHO TRS 1019, raw-material supplier qualification framework, API supplier qualification framework, packaging-material supplier qualification framework, sub-contractor manufacturing qualification framework), EU IVDR (effective stages through 2027/2029) supplier obligations, EU MDR supplier obligations, FDA QSR alignment effective February 2026 (harmonisation to ISO 13485:2016, supplier-controls subpart application), supplier-onboarding modernisation (digital supplier-onboarding framework, supplier risk-assessment automation, supplier audit-readiness framework), AI quality in supplier oversight (AI-augmented supplier risk-monitoring, AI-augmented supplier-document review, AI-augmented supplier-trend analysis, AI-augmented supplier-audit planning), multi-country complexity (US FDA + EU + UK MHRA + Japan PMDA + China NMPA + Korea MFDS + Australia TGA + India CDSCO + Brazil ANVISA + Mexico COFEPRIS + Canada Health Canada + Switzerland SwissMedic), and engagement economics that work for global supplier networks all need to land at the supplier-quality leader layer.

Leaders who build the modern programme take the senior quality work. Leaders who stay on classic checklist-only supplier audits watch the senior work shift to peers.

This course teaches the 10-week build of modern life sciences supplier quality programme: ISO 13485 framework, GMP framework, IVDR/MDR framework, FDA QSR framework, supplier-onboarding framework, audit framework, AI quality framework, multi-country framework, and the executive engagement model. Twelve modules with deliverables. Plus a hand-built implementation playbook for your specific supplier network.

What you walk away with

A documented ISO 13485 supplier framework.
A GMP supplier framework.
An IVDR/MDR supplier framework.
An FDA QSR supplier framework.
A supplier-onboarding framework.
An audit framework.
An AI quality framework.
A multi-country framework.
An executive engagement model.
A 10-week build plan.

The 12 modules

Module 1. Life sciences supplier quality landscape 2026

Detailed walkthrough of the life sciences supplier quality landscape in 2026: lab-services landscape (LGC Group, Eurofins, Charles River, IQVIA, Labcorp, Quest, Sotera Health, BioReliance, WuXi AppTec, Sysmex, Bio-Rad, PerkinElmer Diagnostics), CDMO landscape (Lonza, Catalent, Recipharm, Patheon Thermo Fisher, AGC Biologics, Boehringer Ingelheim BioXcellence, Cambrex, CordenPharma, Curia, Evonik, FUJIFILM Diosynth Biotechnologies, Hovione, Olon, PCI Pharma Services, Piramal Pharma Solutions, Samsung Biologics, Siegfried), medical-device landscape, regulatory landscape (FDA QSR alignment to ISO 13485:2016 effective February 2026, EU MDR + IVDR transitions, FDA, EMA, PMDA, NMPA, MFDS, TGA, CDSCO, ANVISA, COFEPRIS, Health Canada, MHRA, SwissMedic), and the strategic-level decisions facing supplier quality leaders.

Module 2. ISO 13485 supplier framework

Build the ISO 13485 supplier framework: clause 7.4 purchasing process alignment, supplier evaluation framework, supplier-tier framework (critical, major, minor), supplier-controls framework, supplier-monitoring framework, supplier-performance framework, supplier-disqualification framework, and the integration with broader QMS.

Module 3. GMP supplier framework

Build the GMP supplier framework: FDA 21 CFR 211 supplier qualification alignment, EU GMP supplier qualification alignment, PIC/S supplier qualification alignment, WHO TRS 1019 supplier qualification alignment, raw-material supplier qualification framework, API supplier qualification framework, packaging-material supplier qualification framework, sub-contractor manufacturing qualification framework, GxP supplier qualification framework, and the integration with broader GMP programme.

Module 4. IVDR/MDR supplier framework

Build the IVDR/MDR supplier framework: EU MDR supplier obligations alignment, EU IVDR supplier obligations alignment, technical-documentation supplier evidence framework, supplier post-market surveillance framework, UDI supplier framework, EUDAMED supplier framework, notified-body supplier-related engagement framework, and the integration with broader regulatory affairs.

Module 5. FDA QSR supplier framework

Build the FDA QSR supplier framework: FDA QSR final rule (effective February 2026 aligning to ISO 13485:2016) supplier-controls subpart alignment, FDA 820.50 purchasing controls framework alignment, supplier qualification under FDA QSR framework, supplier-audit under FDA QSR framework, supplier-evaluation under FDA QSR framework, supplier-corrective-action under FDA QSR framework, and the integration with broader FDA QSR programme.

Module 6. Supplier-onboarding framework

Build the supplier-onboarding framework: digital supplier-onboarding framework (Coupa, SAP Ariba, Oracle Procurement Cloud, Jaggaer, Ivalua, GEP, Veeva Vault Supplier, MasterControl, in-house), supplier risk-assessment automation framework, supplier-master-data framework, supplier-document framework, supplier-contract framework, supplier-certificate framework, and the integration with broader procurement.

Module 7. Audit framework

Build the audit framework: supplier audit-plan framework, on-site audit framework, remote audit framework, sub-tier supplier audit framework, audit-finding framework, audit-corrective-action framework, audit-effectiveness framework, audit-firm engagement framework (where third-party audit), and the integration with broader assurance.

Module 8. AI quality framework

Build the AI quality framework: AI-augmented supplier risk-monitoring framework, AI-augmented supplier-document review framework, AI-augmented supplier-trend analysis framework, AI-augmented supplier-audit planning framework, AI vendor due-diligence framework, AI governance framework, and the integration with broader AI strategy.

Module 9. Multi-country framework

Build the multi-country framework: US FDA framework, EU framework (EMA, EU member states), UK MHRA framework, Japan PMDA framework, China NMPA framework, Korea MFDS framework, Australia TGA framework, India CDSCO framework, Brazil ANVISA framework, Mexico COFEPRIS framework, Canada Health Canada framework, Switzerland SwissMedic framework, and the integration with broader regulatory affairs.

Module 10. Supplier-development framework

Build the supplier-development framework: supplier-capability-building framework, supplier-training framework, supplier-collaboration framework, supplier-innovation framework, supplier-business-review framework, and the integration with broader supplier strategy.

Module 11. Executive and board engagement

Build the executive and board engagement: CQO partnership, CSO partnership, CPO partnership, CTO partnership, COO partnership, board-quality-committee engagement, audit-committee engagement, and the integration with broader executive cadence.

Module 12. Your 10-week build plan

Week-by-week plan with weekly deliverables. Weeks 1-2: life sciences supplier quality landscape + ISO 13485 supplier framework. Weeks 3-4: GMP supplier framework + IVDR/MDR supplier framework. Weeks 5-6: FDA QSR supplier framework + supplier-onboarding framework. Weeks 7-8: audit framework + AI quality framework. Weeks 9-10: multi-country framework + supplier-development framework + executive engagement. Deliverable: modern life sciences supplier quality programme.

How this addresses your situation

Specific modules that map to what you said you are dealing with.

Module 1 covers the landscape.

Module 2 produces ISO 13485 supplier.

Module 3 covers GMP supplier.

Module 4 covers IVDR/MDR supplier.

Module 5 covers FDA QSR supplier.

Module 6 covers supplier onboarding.

Module 7 covers audit.

Module 8 covers AI quality.

Module 9 covers multi-country.

Module 10 covers supplier development.

Module 11 covers executive engagement.

Module 12 covers the 10-week build plan.

What you get with this course

The 12-module course delivered as text plus downloadable templates.
Templates and worked examples for ISO 13485 supplier framework, GMP supplier framework, IVDR/MDR supplier framework, FDA QSR supplier framework, supplier-onboarding framework, audit framework, AI quality framework, multi-country framework, supplier-development framework, executive and board engagement.
A hand-built implementation playbook generated for your specific supplier network.
Three worked examples of modern life sciences supplier quality programmes at peer firms.
Scripted talking points for the CQO and board-Quality-Committee engagement.

What you will have in hand by Day 1, Week 1, Month 1

Day 1: ISO 13485 supplier framework scaffold drafted.

Week 4: GMP + IVDR/MDR designed.

Week 8: FDA QSR + supplier onboarding + audit + AI quality operational.

Week 10: Programme in operation.

Before and after

Before

Your supplier quality programme handles classic checklist-only supplier audits. ISO 13485 supplier framework strains the operation. FDA QSR February 2026 transition lurks. AI quality is reactive. Senior quality work goes to peers shipping the modern programme.

After

A modern life sciences supplier quality programme is in operation. ISO 13485 supplier framework, GMP supplier framework, IVDR/MDR supplier framework, FDA QSR supplier framework, supplier-onboarding framework, audit framework, AI quality framework, multi-country framework, supplier-development framework, executive and board engagement are all designed.

What happens if you do not address this

Leaders without the modern programme miss senior quality work. FDA QSR transition effective February 2026; EU MDR + IVDR transitions tighten; multi-country supplier-quality requirements expand.

Who it is for

For supplier quality leaders, supplier qualification leaders, GMP audit leaders, supplier audit programme managers, senior quality professionals, and senior quality leaders at life-sciences firms.

Who this is NOT for. Pure clinical-research roles without supplier-quality scope. Practitioners at firms with no life-sciences business. Pure non-quality roles.

How it arrives

Text-based course via LMS, plus downloadable templates and worked examples and the hand-built implementation playbook.

Time investment. Roughly 18 hours of reading and 80 to 160 hours of supplier-quality-leader effort across the 10-week build.

Why $199 is the right number

External life sciences supplier quality consultants (Big4 life-sciences practices like the firm Life Sciences, the firm Life Sciences, the firm Life Sciences, the firm Life Sciences, specialist firms like Emergo, Greenlight Guru consulting, Maetrics, NSF, Oriel Stat A Matrix, McKinsey Pharma, BCG Pharma, the firm Life Sciences, the firm Engineering Life Sciences, the firm Life Sciences, IQVIA Consulting, ICON Consulting, Parexel Consulting) charge $300K-$1.5M for supplier-quality programmes. $199 buys the focused playbook plus the implementation document for your specific supplier network.

FAQ

Will this replace hiring a life-sciences supplier quality consultant?

Partially. It teaches the modern programme. You may still want specialist input for complex FDA QSR transition.

What if my supplier network is primarily lab-services?

Modules 2, 5, and 9 cover lab-services-anchored patterns.

Does this cover combination-product supplier quality specifically?

Modules 3 and 4 cover combination-product patterns.

What about cell therapy and ATMP supplier quality?

Modules 3 and 4 cover ATMP-anchored patterns.

What is in the implementation playbook for me specifically?

Supplier quality framework tailored to your specific supplier network; multi-country framework matched to your specific operating geography; a 10-week build plan.

30-day money-back guarantee. If after a week of working through the materials this is not what you needed, reply to the receipt email and a full refund is processed. No questions, no forms.

Within 24 hours your account in the learning environment is provisioned and the tailored implementation playbook is delivered alongside it.