Short FDA inspection preparation guides
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Short, focused preparation briefs with source context, records to retrieve, questions to discuss, and a practical exercise. Browse descriptions publicly; create a free account to read the complete briefs.
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Contract laboratories · Validation & qualification
Analytical method transfer: rehearse the receiving laboratory handoff
A method arriving from a client is a handoff to examine, not a reason to assume that the receiving laboratory can reproduce the work. Use this exercise to explain the receiving site’s documented readiness for the intended analysis.
Sign in to read →Medical devices · Computerized systems
Device software assurance: begin with intended use and risk
FDA’s February 2026 final software assurance guidance addresses device production and quality management system software. Start with the function’s intended use and the consequence of failure before choosing evidence.
Sign in to read →Laboratories · Testing & laboratory work
Microbiology laboratory: trace a sample through the bench
Follow one sample from receipt to the reported result. Keep the sample identity, handling, method version, media, observations, calculations, and review connected.
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Contract laboratories · Quality & documentation
Laboratory inspection requests: retrieve outsourced raw data together
A report may sit with the client while supporting records sit with the laboratory or an approved subcontractor. Practice a joint retrieval that makes record location, authorized access and explanation responsibilities clear without transferring confidential client files into a training exercise.
Sign in to read →Contract laboratories · Warehousing & distribution
Laboratory sample returns: close the client custody loop
Follow a tested sample into its agreed retention, return or disposition pathway. Focus on the end of the service rather than repeat the sample-receipt exercise. Do not assume one retention period or disposal instruction applies to every product and study.
Sign in to read →Laboratories · Testing & laboratory work
Laboratory analyst handovers: keep unfinished work visible
An unfinished preparation or review can cross a shift boundary. Rehearse a handover that lets the next authorized person understand the actual status from records, including exceptions and work that has not yet been reviewed.
Sign in to read →Contract laboratories · Quality & documentation
Client-supplied specifications: resolve conflicting laboratory instructions
Use a fictional mismatch between a client request, the method packet and a laboratory instruction to practice escalation before proceeding. Avoid deciding that the most recent email automatically overrides an approved specification or agreement.
Sign in to read →Contract laboratories · Quality & documentation
OOS client communication: prepare a factual first update
Practice communicating an unexpected out-of-specification result while an investigation remains open. Separate the observed result, current status, immediate actions and unanswered questions. A first update should not invent a root cause, promise an acceptable retest or pre-judge disposition.
Sign in to read →Contract laboratories · Quality & documentation
Contract laboratory method changes: agree the client decision pathway
Trace a proposed method change through the laboratory and client decision pathway. This is an exercise in clarifying responsibilities and the actual agreed scope; it does not imply that a client’s approval replaces the laboratory’s own responsibilities.
Sign in to read →Laboratories · Validation & qualification
Laboratory service visits: assess the impact on testing
A service visit may change a component, setting or operating condition that matters to the laboratory’s work. Practice explaining the site’s assessment and return-to-use decision rather than treating a closed work order as the entire evidence package.
Sign in to read →Laboratories · Computerized systems
Interrupted laboratory runs: distinguish recovery from a new analysis
Use an invented interruption to examine what the system retained and what the analyst did next. Distinguish resuming work, restarting a run and repeating analysis; avoid assuming that a recovered screen proves the original evidence is complete.
Sign in to read →Laboratories · Computerized systems
Instrument clocks: reconstruct a laboratory event timeline
A cross-system timeline can be difficult to explain when instrument, workstation and laboratory records use different time conventions. Practice reconciling those conventions without silently correcting original records or assuming an offset is harmless.
Sign in to read →Laboratories · Computerized systems
Chromatography reprocessing: explain why the reported result changed
Rehearse an explanation of a changed processing decision using a permitted training dataset. Keep original acquisition evidence, processing choices and review decisions distinguishable. This exercise does not prescribe integration settings or imply that every change is inappropriate.
Sign in to read →Laboratories · Testing & laboratory work
Reference standards: reconcile the certificate, preparation and use
Practice a backward trace from a reported analytical result to the standard actually used. Concentrate on identity and preparation history rather than treating a certificate stored somewhere in the laboratory as the complete explanation.
Sign in to read →Contract laboratories · Validation & qualification
Analytical method transfer: rehearse the receiving laboratory handoff
A method arriving from a client is a handoff to examine, not a reason to assume that the receiving laboratory can reproduce the work. Use this exercise to explain the receiving site’s documented readiness for the intended analysis.
Sign in to read →Contract laboratories · Testing & laboratory work
Virtual contract laboratory inspection: a six-station team walkthrough
A fictional virtual tabletop exercise for contract laboratories, following arrival, sample identity, original data, an amended report, and the team debrief.
Sign in to read →Cosmetics · Cleaning & changeovers
Cleaning verification: separate routine checks from validation claims
Identify the cleaning procedure, routine check, records, and escalation process. Distinguish evidence that a task was performed from evidence supporting a broader validation claim.
Sign in to read →Medical devices · Warehousing & distribution
Warehouse status segregation: test the exception pathway
Select an exception such as a return, damaged receipt, or hold and follow its physical and electronic status. A location name alone does not show that release controls work.
Sign in to read →Contract laboratories · Computerized systems
Laboratory information systems: trace a transferred result
Follow a training result from its source through interface transfer, review, reporting, and retrieval. Determine applicable record requirements and intended use before assigning a validation approach.
Sign in to read →In vitro diagnostics · Packaging & labeling
IVD point-of-care kits: trace the label through a use scenario
Compare the marketed intended user and setting with the kit, instructions, storage information, and studied use. Do not equate point-of-care use with an automatic CLIA waiver.
Sign in to read →In vitro diagnostics · Testing & laboratory work
IVD clinical chemistry: follow a reagent lot transition
Examine the planned change from one reagent lot to another, the supporting evaluation, acceptance rationale, and traceability. Use the product-specific process rather than a universal comparison rule.
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