When FDA Comes Knocking: Warning Letters, Enforcement Signals & What They Mean for 2026 скачать в хорошем качестве

When FDA Comes Knocking: Warning Letters, Enforcement Signals & What They Mean for 2026

FDA enforcement doesn’t start with a shutdown it often starts with patterns: repeat observations, weak CAPA, missing complaint signals, incomplete MDR reporting, and documentation that doesn’t match what’s actually happening on the floor. In this Friday In-Focus session, Michelle Lott, RAC (Regulatory Strategist & Principal Founder of leanRAQA) and Tianna Benson (Senior Consultant, leanRAQA) break down what FDA warning letters and enforcement actions are really telling the MedTech industry and how RA/QA teams can use those signals to strengthen inspection readiness heading into 2026. What you’ll learn: • The most common themes appearing in FDA warning letters and why they keep repeating • How warning letters connect to 483s, CAPAs, complaints, and risk management • The documentation gaps that trigger enforcement (and how to prevent them) • Practical ways to audit your own system before FDA does • What “good” looks like for complaint handling, investigations, and trending • How to respond when FDA finds something and how to avoid making it worse Speakers: • Michelle Lott, RAC — Regulatory Strategist & Principal Founder, leanRAQA • Tianna Benson — Senior Consultant, leanRAQA (Replay + chapters below) 00:00 – Welcome & session overview: what “FDA comes knocking” really means 02:10 – Warning letters vs 483s vs recalls: how the pieces connect 05:15 – Why FDA enforcement signals matter for 2026 planning 08:40 – Top warning-letter theme #1: CAPA breakdowns (root cause, effectiveness, closure) 14:05 – Top theme #2: complaint handling + investigation gaps 20:10 – Top theme #3: MDR reporting, adverse events, and escalation failures 25:30 – Top theme #4: production/process controls and “paper vs reality” 30:45 – Top theme #5: risk management not aligned to post-market signals 36:10 – Data integrity & documentation discipline: the quiet deal-breakers 41:30 – How to self-audit like FDA: practical checklist approach 47:05 – What to do when you receive a 483: response strategy + common mistakes 52:10 – Warning letter response basics: credibility, timelines, containment, and evidence 57:20 – Q&A + real-world scenarios 01:02:30 – Wrap-up: 2026 priorities + final takeaways Friday In-Focus is MLVx’s weekly webinar series—always free, always interactive—spotlighting MedTech’s most experienced thinkers and doers. 👉 Join the MLVx community: https://members.mlvexchange.com 🎟️ Use code SEAN20 to save 20% on membership.