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If you’re involved with inspection readiness or remediation, this conversation with Coruna Medical’s Vice President of Quality, Jeff Hines is a must-watch (or listen).
Jeff sat down with The FDA Group’s Nick Capman to open up his playbook for both of these programs, and went deep on the hard part of remediation, specifically: not just fixing findings under tight timelines, but keeping people confident, calm, and focused while you do it.
With 37 years in pharma across Baxter and Eli Lilly (30+ years), Jeff has lived through the full arc—from reading a daunting 1989 Form 483 packed with data/documentation gaps early in his career, to later leading inspection readiness, responses, and multi-site remediation programs.
His message is practical and refreshingly human: show up calm, build the right inspection infrastructure, communicate transparently, pick your battles, and design systems that prevent repeat issues.
If you’re short on time, here are five moves that change outcomes:
Stand up the four-room model (Front, Back, Doc-QC, SME-Prep) and rehearse how requests flow.
Teach inspection behavior explicitly (scope discipline, pausing, routing), not just SOP content.
Decide disagreements strategically; don’t prolong inspections on marginal wins. Align the “why” internally.
Map your data flows and close audit-trail/control gaps with IT involved from day one.
Refresh the org annually on shifting expectations. Share outside observations and update procedures promptly.
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What Jeff covers here
The leadership posture that steadies teams across PAI, routine, and for-cause inspections.
A simple but powerful front-room/back-room model (plus two additional “rooms”) that accelerates inspections and reduces rework.
How to train for inspections (it’s not the same as SOP training) and grow the next bench of SMEs.
Responding to observations when you disagree—including when to push, when to accept, and how to explain the strategy internally.
Prioritizing remediation work while operations continue.
Data integrity realities (what inspectors look for, how to close gaps, and interim controls that actually work).
Building a culture where transparency runs both ways and first-time mistakes are surfaced early.
Staying current so you don’t backslide into repeat findings.
Jeff’s story: foreshadowing a remediation career
Early at Baxter, Jeff was handed a thick document: Eli Lilly’s 1989 Form 483—well over a hundred observations, heavy on data/documentation, method validation, and retest/resample controls. Reading it was “terrifying”—and clarifying. Soon after, he joined Lilly, where one of his first assignments was executing validation work to close items from that very 483. It was, as he puts it, a preview of the inspection-readiness and remediation leadership he’d practice for decades.
The leadership posture: calm, confident, concise
Across PAIs, routine, and for-cause inspections, Jeff says his constant is leadership presence:
Be visibly engaged. People take their cues from you. Your composure sets the room’s temperature.
Instill confidence without oversharing. Train staff to answer the question asked—not to deliver a lecture that invites new threads.
Normalize the nerves. Remind operators and analysts that no one knows their job better than they do—and that the inspection is a chance to show it.
The inspection infrastructure that actually works
Jeff’s preferred model pairs quality and technical leadership and runs on four coordinated “rooms”:
The Front Room: Led jointly by Quality + Technical Services so technical questions get crisp, immediate answers—reducing the urge for investigators to dig further.
The Back Room: Fast document/data retrieval by people fluent in IT systems (where data and SOPs live). Use Teams/Zoom chat to transmit requests as they’re spoken so pulling starts before the paper request arrives. Speed matters.
The Document QC Room: SMEs pre-review documents for completeness, accuracy, and unintended “loose threads” before they reach the investigator
SME Prep/Coaching Room: Role-play likely questions. Reinforce plain-spoken answers and scope discipline. The goal is less theater, more calm rehearsal so people walk in confident.
Jeff’s pro tip: Don’t assume your QMS training covers inspection behavior. Teach teams how to handle an inspection—what to say, what not to say, how to request time, and how to route requests. It’s high-ROI and keeps the process smooth. Also, develop your bench. Don’t rely on the same “go-to” SMEs forever.
Handling observations (especially when you disagree)
Disagreement is inevitable. The question is what to do next—and what message your choice sends internally.
Choose battles strategically. Jeff recalls receiving an observation for deviating from the USP’s six-injection system suitability (adopting three injections with a tighter RSD). Despite data and logic, the team accepted the observation and reverted—because the fight risked prolonging and complicating the outcome for marginal gain.
Explain the “why” to your team. Even if you personally disagree, your job is to align the organization around the response strategy and keep morale intact.
When stakes are high (e.g., sterility assurance and expensive facility changes), escalation and extended back-and-forth may be warranted—but expect long timelines and an inspection that stays open until resolution.
Leadership behaviors that help:
Own the outcome: “When it’s good, it’s the team; when it’s bad, it’s on me.”
Pair truth + hope: be candid about the issue and clear about the path out—people can carry tough news if they can see forward progress.
Keep tone measured: no blame-shifting, no dramatics. Steady wins trust. One thing to bring back to your team
Balancing remediation with live operations
You rarely get the luxury of stopping the plant. Here’s Jeff’s playbook for remediation:
Co-prioritize with the team. Put stability first (long-lead tests like sterility), then pre-fill tests (to keep tanks moving), then specials.
Borrow capacity. Temporarily pull trained people back from other areas if they’ve done the work before.
Reset customer expectations. Some projects pause while you clear must-do work.
Use a visible project tracker and get early wins—turn some red to green quickly to build momentum and morale.
Data integrity: where gaps hide—and how to close them
A recurring theme in recent inspections is deep software and audit-trail scrutiny. Jeff has seen inspectors who know a given platform well enough to navigate to corners that allow audit-trail edits or data deletion—even when no one on the site knew those pathways existed.
What worked in the interim:
Real-time second-person verification during critical lab runs (observe, attest, document) to ensure no manipulation can occur while permanent fixes are scoped and implemented.
Data flow maps—from test initiation to result—pinpointing every system handoff, file write, audit trail, and human touchpoint. This becomes the basis for training, access controls, and monitoring.
Pull in IT early. Don’t leave analysts to reverse-engineer system behavior; pair them with people who understand storage, roles/permissions, and log structures.
Preventing backsliding into repeat findings
Avoiding déjà vu requires staying current and institutionalizing what you learn:
Monitor expectations continually. Regulations are the floor. Investigator focus evolves.
Invest in conferences, publications, and internal GMP updates to propagate changes and lessons (including observations at other companies).
Update procedures accordingly and retrain—with clarity about what changed and why.
Treat quality as a value center: prevention costs less than remediation—and it protects patients and the business.
One thing to bring back to your team
Pick one high-visibility lab or manufacturing process.
Create a one-page data-flow map showing every handoff and audit trail.
Tighten access roles and document who can do what.
Add a brief inspection-handling refresher for the involved team: how to answer, escalate, and request time.
Dry-run the Front/Back/Doc-QC/SME-Prep flow on a mock request.
Jeff Hines is Vice President of Quality at Coruna Medical. He previously spent 30 years at Eli Lilly and earlier time at Baxter. His focus over the last several years has included inspection readiness, response, and remediation leadership across labs and manufacturing.
Connect with him on LinkedIn here.
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