Expert Answers
Expert Answers
Questions we are asked regularly, answered directly by the consultant who does that work. Each answer names its author, states the position in the first paragraph, and links to the underlying regulation or guidance where one applies.
- Quality SystemsDusty Snoeberg-Renwick
What does a former FDA investigator look for in a quality system?
Whether the system described on paper is the system the organization actually runs. An investigator follows a small number of records end to end — a complaint, a deviation, a batch, a change — and checks that each handoff happened when the procedure said it would, by someone qualified to make the decision.
- Medical DevicesLisa Hornback
What does QMSR mean for medical device manufacturers?
FDA's Quality Management System Regulation replaces the Quality System Regulation in 21 CFR Part 820 by incorporating ISO 13485 by reference, effective February 2, 2026. For most manufacturers already certified to ISO 13485 the change is one of terminology, documentation mapping and record expectations rather than a wholesale system rebuild.
- Medical DevicesChristopher Smith
What are the most common design control weaknesses in medical devices?
Design inputs written as marketing statements rather than verifiable requirements, verification that does not trace to a specific input, and design changes made after transfer without returning to the design file. Nearly every design control observation traces back to one of those three.
- IVD & DiagnosticsTimothy Couzins
When should an IVD company bring in outside regulatory or quality support?
Before the first submission-supporting study is designed, and again at the point of scale-up. Diagnostic companies most often need help when analytical and clinical performance work has been executed well scientifically but documented in a way that does not support a regulatory claim.
- Dietary SupplementsSteve Yost
What are the most common 21 CFR Part 111 quality-system weaknesses?
Incoming component identity testing that is skipped or delegated to a supplier certificate without qualification, master manufacturing records that do not match what production runs, and finished-batch release decisions made without complete specification testing.
- Dietary SupplementsMarianne Allen
How should a dietary supplement manufacturer qualify its suppliers?
With a written program that assigns risk by ingredient, defines what evidence is required at each risk level, and re-evaluates on a stated interval. A supplier list with certificates attached is not a qualification program.
- Laboratory GMPJohn Crowe
What are the most common laboratory data-integrity failures?
Unreviewed audit trails, shared analyst logins, and sample or injection sequences that were repeated without a recorded reason. In most cases the underlying cause is a laboratory under schedule pressure with system configuration that permits shortcuts.
- Laboratory GMPTerri Dodds
What goes wrong most often in OOS investigations?
Retesting before the laboratory phase is complete, invalidating an original result without identifying an assignable cause, and closing the investigation without deciding whether other batches are affected.
- Laboratory GMPJoseph Mastronardy
What is the difference between method validation and method transfer?
Validation demonstrates that a method is suitable for its intended purpose. Transfer demonstrates that a second laboratory can execute that validated method and obtain equivalent results. They answer different questions, and one does not substitute for the other.
- Clinical QualityJennifer Menendez
What is the role of BIMO in clinical quality oversight?
FDA's Bioresearch Monitoring program evaluates whether clinical data submitted to the Agency were generated under adequate controls — covering sponsors, monitors, CROs, investigators and IRBs. For a sponsor, BIMO expectations are best treated as the design specification for the clinical quality system, not as an inspection exercise.
- Clinical QualityGregory Jean-Noel
What does adequate CRO and vendor oversight look like?
A documented qualification decision, a quality agreement that names deliverables and escalation paths, periodic review of the vendor's performance against defined metrics, and a record of what the sponsor did when performance slipped.
- Quality SystemsRobert Fannon
When should a company bring in outside CAPA remediation support?
When the same problem has recurred after a closed CAPA, when the backlog is growing faster than it closes, or when the people who would run the remediation are the same people who own the process being remediated.
- ValidationShane Snoeberger
What are the most common process validation weaknesses?
Acceptance criteria that were not derived from process understanding, a continued process verification stage that exists only on paper, and revalidation triggers that are never actually evaluated after changes.
- Medical DevicesFinn Alexander Slizza
How should CAPA effectiveness be verified in a device quality system?
By measuring the thing that failed, over a period long enough for it to fail again, against a criterion defined before the corrective action was implemented. Confirming that training was delivered is not an effectiveness check.
- IVD & DiagnosticsDeena Venezia
How much quality system does a growing diagnostic company actually need?
Enough to control the records that a future submission and a future inspection will depend on — document control, design control, supplier control and training — and no more than the current headcount can sustain.
Topics covered: Medical Devices · IVD & Diagnostics · Dietary Supplements · Laboratory GMP · Clinical Quality · Quality Systems · Validation
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