The process of assuring FDA compliance to quality system requirements is different for every company, depending on company size, operations, and priorities. Current good manufacturing practice (cGMP) requirements are set forth in FDA’s Quality System (QS) regulation. The requirements in the QS regulation and in 21 CFR 820 govern the methods used in, and the facilities and controls used for, the design, manufacture, packaging, labeling, storage, installation, and servicing of all finished devices intended for human use. The requirements are intended to ensure that finished medical devices will be safe and effective and otherwise in compliance with the Federal Food, Drug, and Cosmetic Act. The QS regulation establishes basic requirements applicable to manufacturers of finished medical devices.
In the QS regulation, FDA has identified the essential elements that a quality system shall embody, without prescribing specific ways to establish these elements. Because the QS regulation covers a broad spectrum of devices and production processes, it allows some leeway in the details of quality system elements. It is left to manufacturers to determine the necessity for, or extent of, some quality elements, and to develop and implement specific procedures tailored to their particular processes and devices.
This interactive course will provide guidance and direction that will allow you to develop strategies, add business value, and minimize delays by providing strategic/tactical solutions that facilitate the achievement of regulatory and quality milestones.
Take advantage of our $1,595.00 price by registering early! * After January 19, costs are $1,795.00.