Prepare for FDA QMSR Inspections: 483 & Warning Letter Response

Overview:

FDA inspections under the new QMSR can look and feel different—not just in what investigators prioritize, but also in what information they can request and review. In this webinar, we will explain how QMSR has expanded FDA’s inspection rights and what that means in practical terms for regulated companies. Specifically, we’ll clarify the processes and documents FDA is now allowed to inspect, including management reviews and supplier and internal audits, and what FDA is expecting to see when these records are requested.

FDA is required to conduct an inspection every two years, and preparation directly impacts how smoothly that inspection goes. A company that is prepared is less likely to receive 483’s than an unprepared company. If a 483 is issued, a well-informed and timely response can lessen the chances of receiving a Warning Letter. We will break down what “prepared” looks like: how to assign responsibilities, how to organize people and information, and how to support an inspection so responses are consistent, accurate, and controlled.

We’ll also describe the new remote Regulatory Assessment, which allows FDA to request documents for review prior to an inspection—enabling investigators to focus the on-site portion on suspect areas. By attending, you will learn how to prepare for a QMSR-based inspection and how to respond if you receive a 483 or Warning Letter. We will cover inspection types, planning and role assignments, facility setup (front room/back room), the value of internal and mock audits, how to conduct yourself during an inspection (including what not to sign), the inspection process itself, and the documentation FDA can now require under QMSR.

Areas covered in the session:

• New FDA inspection rights under the QMSR
• Personnel preparation
• Procedure to follow during audit-what to do/ what not to do
• Facility requirements to support inspection
• Behavior during inspection-what not to sign
• Internal/ mock audits
• 483/ Warning Letter response

Why should you attend?

FDA inspections under the new QMSR can involve broader document access and different inspection focus areas than many companies are used to. This session helps you understand what FDA can now ask to see—including management reviews and internal/supplier audit records—and what that means for your day-to-day inspection readiness.

You’ll also learn how to prepare in a practical, organized way: who should do what before and during the inspection, how to set up the front room/back room, how to manage requests and communications, and how your team should conduct themselves while FDA is on site.

Finally, if you do receive a 483 (or a Warning Letter), this webinar walks through how to respond appropriately and reduce the chance of escalation. You’ll also learn how the remote Regulatory Assessment works, so you’re better prepared when FDA requests documents before the inspection and uses them to narrow in on suspect areas.

Handouts:

Attendees will gain access to exclusive handouts, including presentation materials provided by the speaker and additional resources developed by Amorit Education to support post-session implementation, such as:

• Inspection readiness checklist
• FDA Inspection Request Log + Document Production Workflow Template (PDF)
• Remote Regulatory Assessment Response Playbook (PDF)
• Inspection Roles & Responsibilities (RACI) + Escalation Tree (PDF)

Who will benefit?

This webinar will benefit professionals responsible for FDA inspection readiness, QMS compliance under QMSR, audit programs, and managing inspection communications and outcomes (including 483 and Warning Letter responses). Those include:

• VP, Quality Assurance (QA)
• Director of Quality Assurance
• Quality Systems Manager / Director
• Quality Compliance Manager
• Regulatory Affairs Director / Manager
• Director of Regulatory Compliance
• Head of Inspection Readiness
• FDA Inspection Program Manager / Inspection Coordinator
• CAPA Manager / CAPA Program Owner
• Document Control Manager / Document Management Lead
• Internal Audit Manager / Lead Auditor
• Supplier Quality Manager / Supplier Quality Engineer (SQE)
• Quality Audit Program Manager
• Quality Engineering Manager
• Manufacturing Quality Manager
• Validation / Compliance Manager (CSV/CSA/Quality)
• Quality Risk Management Manager
• Complaint Handling / Postmarket Surveillance Manager
• Operations / Plant Manager (site inspection lead)
• Quality Management Representative (QMR) / Management Representative
• General Manager / Site Head (for regulated facilities)