Process Development and Quality Systems for Medical Devices

BIOENGR X 430.3

Gain a foundation for medical device industry professionals seeking to solidify their understanding of quality systems requirements and applications.

READ MORE ABOUT THIS COURSE
Fall
Spring
Online
Starting at $999.00
As few as 11 weeks
4.0
3.3

What you can learn.

  • Identify best practices to address requirements for product design and process development
  • Develop a product design and perform risk management activities
  • Design validation and verification activities
  • Design transfer to manufacturing
  • Establish a controlled manufacturing process

About this course:

This course provides a foundation for medical device industry professionals seeking to solidify their understanding of quality systems requirements and process development best practices. This enables them to successfully engage within medical device product development teams in an industry setting, scope efforts appropriately, and reduce compliance risks. The course focuses on identifying best practices to address the relationship between product design and process development. Students learn an overview of design controls, requirements for medical device process validation, statistical tools used to characterize and optimize processes and designs, process validation and strategies to develop robust manufacturing processes, and use of statistical software (Minitab).The tools used in this course require a PC/Laptop with a Windows Operating System and MAY NOT BE compatible with other operating systems.

Fall 2020 Schedule

Available Format(s):

These courses are fully online and have no regular meeting times.

Future Offering (Opens August 03, 2020 12:00:00 AM)
-
This section has no set meeting times.
Instructor: David Law
375325
Fee:
$999.00
See Details
Notes

Enrollment limited; early enrollment advised.

Refund Deadline
No refunds after October 12, 2020
Course Requirements
Internet access required to access course materials.

Contact Us

Our team members are here to help. Hours: Mon-Fri, 8am-5pm

This course applies towards the following certificates & specializations…

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