Instructor
Edwin Waldbusser
In this webinar you will learn how to prepare for a QMSR based inspection and how to respond to a 483 or Warning letter if you receive one.
You will learn about the types of FDA inspections, preparations such as assigning personnel to specific tasks for the inspection, facility requirements to support the inspection (front room, back room), the value of mock audits, how personnel should conduct themselves during the inspection, the inspection process and how to respond to 483s and warning letters. We will cover the FDA’s new inspection rights under the QMSR and the documentation you are now required to show them.
The new QMSR has changed FDA inspection rights and priorities. The processes and documents FDA is now allowed to inspect will be explained. FDA can now inspect management reviews, and supplier and internal audits. We will explain how to meet these new FDA expectations.
FDA is required to conduct an inspection every two years. A company that is prepared for the inspection is less likely to receive 483’s than an unprepared company. If a 483 is received, knowing how to respond will lessen the chances of receiving a Warning Letter.
The new “remote Regulatory Assessment’ will be described. It allows FDA to request documents for their review prior to an inspection. They can focus their inspection on suspect areas.
Handout is inspection readiness checklist
