Design Controls

Virtual Learning

October 21 – 22, 2020

Course Overview

This fully online 2-day training course on Design Controls is highly interactive and includes case study exercises, competency assessment, and a Certificate of completion.

This training will provide an understanding of the risk management and design and development regulatory requirements relative to FDA’s 21 CFR 820, ISO 13485:2016 and EU regulations; as well as practical examples of to how to minimize inefficient executions and documentation practices. Benefit is gained through open dialogue and sharing of current design and development processes to highlight how misperceptions of regulatory requirements have led to less than optimal practices. This course will provide knowledge to assist in all phases of design and development projects.