Bundle — Save 72%
FDA Inspection Ready Bundle
The 5 toolkits FDA investigators look hardest at — CAPA, design controls, complaint handling, process validation, and supplier controls. Built to get Class II manufacturers through an inspection.
$347$1,235 if bought separately
5 toolkits. One payment. Instant download.
Get the bundle — $347 →Instant download. 30-day refund if not useful.
What's included
✓CAPA procedure, root cause analysis templates, effectiveness check protocol, trend analysis dashboard.
✓Design Controls Toolkit
$247Design plan, inputs/outputs, V&V protocols, DHF structure, design review checklist.
✓Complaint Handling & MDR Reporting Toolkit
$247Complaint procedure, MDR decision tree, investigation form, non-reportable justification template.
✓Process Validation (IQ/OQ/PQ) Toolkit
$247IQ/OQ/PQ protocol templates, worst-case parameter guidance, revalidation trigger checklist.
✓Supplier Controls & Qualification Toolkit
$247Supplier qualification procedure, ASL template, audit checklist, quality agreement, performance scorecard.
Total value$1,235
Who it's for
→QA managers preparing for an FDA 483 or warning letter response
→Contract manufacturers building their QMS from scratch
→Consultants helping Class II device manufacturers pass their next inspection
This bundle is for informational purposes only. Not legal or regulatory advice. Consult a qualified regulatory affairs professional for your specific situation.
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