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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

Tickets

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Design Control - Member
Employees of Oregon Bioscience Association member companies receive discounts on BioPro classes. Visit the Membership Directory for a list of current member companies.
$ 375.00
19 available
Design control - Non Member
$ 475.00
19 available

Details

Start:
August 26 @ 8:00 am
End:
August 27 @ 12:00 pm
Cost:
$375 – $475
Event Categories:
,

Organizer

Oregon Bioscience Association
Phone:
(503) 548-4432
Website:
https://www.oregonbio.org/

Venue

Oregon Bio Virtual Classroom
OR United States + Google Map
Phone:
503-953-3145