Curriculum
- 5 Sections
- 20 Lessons
- 1 Day
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- Transformation Imperatives in Med-Device Supply Chains4
- 1.1Drivers of Business Transformation in MedTech: global regulatory tightening (EU-MDR/IVDR, FDA QMSR), cost-to-serve pressures, post-COVID resilience needs, ESG & traceability demands.
- 1.2Supply-Chain as a transformation lever: enabling quality-compliant speed-to-market and cost agility
- 1.3Core frameworks & maturity models: SCOR-SCM, 5 Ps of Transformation (People-Process-Platform-Performance-Partners), twin-transition (Digital + Sustainable).
- 1.4Key Med-Device Terms: UDI, e-IFU, PMS, CAPA, cold-chain compliance, lot-traceability, GxP logistics
- Readiness Gaps & Emerging Risks4
- 2.1Macro-trends: near-shoring vs global sourcing, supplier-qualification hurdles under MDR/IVDR, digital-twin visibility, cyber-secure device distribution.
- 2.2Transformation archetypes: regulatory-driven, cost-take-out, growth-enablement, sustainability-mandated
- 2.3Risk & readiness assessment: People / Process / Tech / Compliance / Partners
- 2.4Change-management challenges: QA-Ops alignment, data-integrity in ERP/eQMS, multi-jurisdiction customs & import/export compliance.
- Lessons from the Med-Device Field5
- 3.1Case 1 – EU-MDR transition: redesign of supplier network & labelling to sustain CE-mark
- 3.2Case 2 – US-FDA QMSR alignment: harmonising global sites’ QMS & SC metrics
- 3.3Case 3 – Cold-chain-sensitive diagnostics: balancing GDP/GMP compliance with cost-to-market
- 3.4Case 4 – Digital-twin rollout: predictive risk-response for component shortages during a recall
- 3.5KPIs that matter – OTIF in regulated shipments, lot-trace compliance, NC/CAPA cycle-time, lead-time compression
- Readiness in Action4
- 4.1Heat-Map Workshop: score own SC maturity & compliance risk exposure
- 4.2Scenario Simulation: respond to disruption (supplier non-conformance / sudden reg-change) using resilience levers
- 4.3Stakeholder-Mapping Game: identify QA/RA, Ops, Supplier, and Commercial champions & blockers
- 4.4Linking supply-chain readiness with transformation success & regulatory continuity
- Wrap-Up & Key Take-Aways3
Drivers of Business Transformation in MedTech: global regulatory tightening (EU-MDR/IVDR, FDA QMSR), cost-to-serve pressures, post-COVID resilience needs, ESG & traceability demands.
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Core frameworks & maturity models: SCOR-SCM, 5 Ps of Transformation (People-Process-Platform-Performance-Partners), twin-transition (Digital + Sustainable).
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