CDRH Industry Basics: Quality System

The Quality System (QS) Regulation is a must-known for the device industry and the production and process control subsystem is a key part of it. Two important parts of the production and process control subsystem are purchasing controls and process validation. Our presentation and Q/A will explain both the regulatory requirements and best practices for each item. Purchasing Controls – In an ever expanding global economy, outsourcing has become the norm, be it for materials, manufacturing or services. This industry basics session will educate you on both the regulatory requirements, per 21 CFR 820.50, from FDA and the expectations and guidance available Process Validation – How do you ensure medical devices are manufactured in a consistent and reproducible way so processes result in devices that meet specifications? This is where process validation comes in to play. In this industry basics session you will be provided information on the 21 CFR 820.75 Quality System regulatory requirements for process validation. Also covered will be suggestions and best practices to determine when and how to perform valuable process validation.