Design Control Program

Training Duration: 2 days

This course covers the basic concepts for implementing and maintaining a design control program. In addition to understanding why the design control program is needed, tools (Forms and Templates) and techniques are provided on how to effectively perform the design control program. This course should be mandatory for any person in the engineering or QA departments who handles design control activities such, developing new devices from conception to transferring of technology to production and maintaining effectively the Device History File (DHF).

Training Features

Training on each element of the design control process and their requirements.
How to write effectively each phase of the design control process.
Content focuses on the medical devices common design control practices per federal regulation and industry standards.
How to effectible comply with FDA expectations regarding the design control process.
Information on what to expect during FDA design control inspections.

Training Benefits

Employees will have and increase knowledge of how effectively comply with the design control process.
Increase design control technical writing.
Employee increase performance, less mistakes due to lack of basic understanding of the design control regulations.

International Quality Consulting bring a diverse team of consultants to our clients. We are constantly expanding our roster of internationally recognized associates. Our trainers and consultants average over 30 years experience in the FDA regulated environment – many of which are ex-FDA. Our associates bring a wealth of experience to help meet your consulting and training needs.