Course Dates Upcoming Dates and Locations Virtual seminars run as 1/2-day sessions. In-person classes run as full-day sessions. See the virtual session daily class times. There are no public training classes scheduled right now but this class can be delivered privately to 6 or more people at any time. Ask us for details!
Course Details Objectives At the end of this course, participants will be able to: Describe the objectives of ISO 13485:2016 and FDA's QSR Identify the requirements of ISO 13485:2016 and FDA's QSR Apply the requirements of ISO 13485:2016 and FDA's QSR Identify the common elements found in global QMS requirements Describe how to plan and prepare for FDA, Notified Body, and MDSAP inspections/audits Topics FDA QSR background and subpart review compared against ISO 13485 standard clauses Major subsystems: management controls, design controls, production and process controls, and CAPA Application of risk-based approach Who Should Attend This course is appropriate for anyone who needs to understand how to meet the requirements of a global medical device quality system, including R&D or engineering managers; management representatives; product, project, and program managers; RA/QA managers/engineers; internal auditors; compliance and legal; and other cross-functional team members. Virtual Class Days The virtual version of this class is delivered as five consecutive half-day sessions. Daily sessions run from 1:00-5:00 p.m. Eastern Time. Virtual Half-Days In-Person Full-Days CEUs 2.4