Curriculum
- 5 Sections
- 20 Lessons
- 1 Day
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- Foundations of MDSAP4
- 1.1Evolution of MDSAP: Regulatory rationale & global acceptance
- 1.2Participating authorities: FDA, Health Canada, ANVISA (Brazil), TGA (Australia), PMDA (Japan)
- 1.3Alignment with ISO 13485:2016 and GHTF principles
- 1.4Key Terms: Audit Model, Audit Task, Audit Companion Document, Jurisdictional Requirements.
- Audit Model & Jurisdictional Requirements6
- 2.1MDSAP audit structure: Chapters, tasks, linkages
- 2.2Country-specific nuances: FDA: 21 CFR Part 820 vs. ISO 13485
- 2.3Country-specific nuances: Health Canada: MDSAP as mandatory
- 2.4Country-specific nuances: PMDA/TGA: localized expectations
- 2.5Case discussion: How one company aligned global QMS with multiple regulators
- 2.6NC grading, MDSAP Audit Cycle, Country-Specific Addenda
- Practical Challenges & Case Insights5
- 3.1Common nonconformities raised in MDSAP audits
- 3.2Case studies: FDA finding vs. ISO 13485 compliance gap
- 3.3Case studies: Health Canada transition case during MDR migration
- 3.4Risk-based thinking: linking CAPA, internal audits, and management reviews
- 3.5Risk Priority, CAPA Effectiveness, Escalation Process, Supplier Controls
- MDSAP Readiness Challenge2
- Strategy & Wrap-Up3
Linking MDSAP readiness to corporate objectives: faster approvals, fewer market delays
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