Risk Management
Omnex Upcoming Webinars for June 2022
Three upcoming webinars are available to increase participation and understanding within the world of quality assurance.
Published: Monday, June 13, 2022 – 12:51
(Omnex: Ann Arbor, MI) — Omnex has announced three new webinars for June 2022.
Webinar name: Proposed Changes to 21 CFR 820
Date and Time: Jun 14 2022 11:00 a.m. Eastern Time
The FDA regulatory requirement 21 CFR 820 for medical device Current Good Manufacturing Practice (CGMP) for Quality System Regulations (QSR) is undergoing a significant revision. The purpose of this webinar is to familiarize medical device manufacturers who are marketing or intend to market in the USA with the proposed upcoming changes.
Though the standard has been around since 21 Jul 1978, the FDA is proposing to amend regulations to align more closely with the international consensus standard for devices by converging with the Quality Management System (QMS) requirements used by other regulatory authorities from other countries. They are therefore incorporating the international standard ISO 13485:2016 into CFR 820.
This action, when finalized, is expected to align the…
