QMS Training for Medical Devices: FDA QSR and ISO 13485:2016

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
• Identify opportunities beyond compliance, including FDA’s Case for Quality

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
• Going beyond the minimum requirements, including FDA's Case for Quality

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.

Related Courses

• ISO 13485 Lead Auditor Training

Virtual Session Details

Oriel STAT A MATRIX is known for our in-person workshops and hands-on activities, and we use an extensive toolbox to foster similar engagement and attention in our virtual classes. Our instructor and students interact in real time via our flexible, online learning platform, resulting in an engaging and real-class environment.

This is an ideal alternative to the typical classroom setting for quality and regulatory professionals who are unable to travel or who just prefer the convenience of attending a class without having to leave their own personal environment.

Virtual Instructor-Led Training Schedule

• This training is delivered as five consecutive half-day sessions.
• Daily sessions run from 1:00-5:00 p.m. Eastern Time.
• This convenient half-day format allows you to balance your other responsibilities while still getting the training you need. 

Technical /Logistical Requirements

To participate in this learning, first and foremost, we need your engagement!  You will also need:

See course dates to find / register for a virtual online session of this course.