Design Control – Online

Loading Events
  • This event has passed.

Training Dates: August 26 and 27, 8 a.m. – 12 p.m.

Overview:
In this “hands on” course participants will design a product utilizing regulations for design control and application of risk management. Participants will learn how to perform risk management, plan design activities, determine design inputs and outputs, verification, validation, how to handle design changes, and the contents and maintenance of a Design History File.

By the end of the course, participants will be able to:

  • Describe FDA Regulations for Design Controls
  • Perform product risk management for design control
  • Perform design planning
  • Identify design input and outputs
  • Perform a design review
  • Identify design verification and validation
  • Perform design transfer
  • Perform design changes
  • Maintain a Design History File

Who Should Attend:
Although Design Control is a regulation for medical devices, those who are involved with any part of product development in a regulated environment are encourage to attend. This can include purchasing, quality, regulatory, manufacturing, product development, as well as other functions.

Prerequisites:
No pre-requisites required. Overview of FDA Regulations and Quality Systems Overview (or relevant experience) are highly recommended.

Cost: One-day class

Location: Oregon Bio Virtual Classroom

Details

Start:
August 26, 2020 @ 8:00 am
End:
August 27, 2020 @ 12:00 pm
Cost:
$375.00 – $475.00
Event Categories:
,

Venue

Oregon Bio Virtual Classroom
ORUnited States+ Google Map
Phone
503-953-3145

Tickets

The numbers below include tickets for this event already in your cart. Clicking "Get Tickets" will allow you to edit any existing attendee information as well as change ticket quantities.
Tickets are no longer available