Breakout 4: Inspection Readiness Starts on Day One
Ready or Not – Inspection Readiness under R3Inspection readiness isn’t an end-of-study fire drill. This session focuses on embedding inspection readiness from the very beginning, aligned with R3 expectations.
Facilitator: Dani Eaton
Bio
Dani Eaton has been working in Clinical Quality Assurance for over 20 years, focusing on risk-based auditing, Inspection Readiness and Inspection Management. She started her career in the GLP QA group at Human Genome Sciences before moving into the GCP QA team. She then joined the CRO world spending 11 years at PRA Health Sciences where she developed Inspection Readiness programs and supported inspections by both FDA and EMA, in addition to various MOHs. She has spent 7 years in the cell and gene therapy (CGT) world on the sponsor sides at bluebird bio and Rubius Therapeutics heading up the Clinical QA function. For the last 6 years, she has been providing Clinical QA/GCP consulting for small clinical stage Biopharmaceutical companies, with a focus on CGT.
In her spare time, Dani enjoys exploring the world with her husband and daughter, and cheering on the Virginia Tech Hokies and Boston Red Sox.
Discussion Subtopics
- “Start with the end in mind”: planning for inspections from day one.
- What inspectors now expect sponsors to show versus just say.
- Mock inspections and gap analysis: strategies that actually prepare teams.
- Real-world lessons from recent inspection findings under evolving frameworks.
Did You Miss a Conversation? Catch Up On Session All Breakouts Here
Breakout 1
Different Maps, Same Destination: Interpreting Oversight Under R3
Breakout 2
Data Under Pressure – Integrity and Systems in the R3 Era
Breakout 3
Using Proportional Risk to remain “Small but Mighty”
Breakout 4
Ready or Not – Inspection Readiness under R3
How Seuss+ Supports Continuous Inspection Readiness
At Seuss+, we understand that being inspection-ready means building audit confidence into every part of your clinical trial operations. That’s why our Vendor Relationship Maximization Method (VRMM) includes documentation frameworks, governance SOPs, and escalation pathways that meet ICH-GCP standards—while remaining manageable for lean teams.
Sponsors we’ve worked with have:
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Passed inspections with zero findings on vendor documentation.
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Become inspection-ready in as little as 3 months with tailored SOPs and lean QMS setup.
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Avoided costly rework by embedding clear issue and decision tracking from Day One.
You don’t need more process, you need the right ones.
Let’s build an infrastructure that prepares your trial for what comes next, from audit to market.