Prepare for FDA QMSR Inspections: 483 & Warning Letter Response

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.