Digital Quality & ComplianceComing soon
Course facts.
LevelIntermediate, for people who work with validated systems
PrerequisiteCSV & CSA Essentials or equivalent working knowledge
FormatLive first, then self-paced chapters
Completion windowOne month from enrolment
AssessmentGraded, with certificate on passing
Who this course is for.
Built for working professionals
If you work in industry
You inherited validated systems. Keep them defensible without drowning your team in paper.
Course outline▼
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Click a module to see every lesson.
01
Validation planning & strategy
Build a risk-informed validation plan from scratch.
- 1.1 Understanding system risk: where validation begins
- 1.2 Building a validation plan: scope and strategy
- 1.3 Interpreting the User Requirements Specification (URS)
- 1.4 Planning the lifecycle: milestones, deliverables and stakeholders
02
Testing & documentation
Turn requirements into defensible, risk-based testing.
- 2.1 Turning requirements into risk-based testing: FRS and functional-level risk assessment
- 2.2 From design to testing: DS, CS and the test plan
- 2.3 Authoring IQ/OQ/PQ protocols with end-to-end traceability
- 2.4 Test execution, deviations and reporting
03
Change control & periodic review
Keep validated systems compliant after go-live.
- 3.1 Managing change: change control and impact assessment
- 3.2 Managing software updates in GxP systems
- 3.3 Planning and documenting periodic reviews
04
Audit readiness
Face an inspection with confidence.
- 4.1 Preparing for inspections: what auditors look for and common FDA findings
- 4.2 Demonstrating compliance with the traceability matrix
- 4.3 CAPA: correcting issues and preventing recurrence
- 4.4 Conducting a mock audit
This course is in production and the outline is confirmed. Join the waitlist and we will tell you the moment enrolment opens. Waitlist demand also decides which course we launch next.
What you leave with
A certificate of completion and templates you can adapt on the job.
Enrolment, waitlists, payment and delivery run on our learning platform at learn.ada.archimedis.io.