Design Controls Module 9:
Design Changes

This module of the Design Control Series explores the requirements for design changes and implementation tools to meet the regulatory requirements in a 1.5-hour webinar. Participants discuss an approach to analyze impact of design changes to ensure all portions of your design controls are addressed (e.g., repeating verification testing, updating risk management file, updating component specification, repeating process validation. A question and answer session takes place after the main presentation.

Expert Faculty

Pat Baird
Product Design Owner
Baxter Healthcare

Michelle Keyzer
Product Development and Engineering Manager

(Expert faculty titles and companies may have changed since the time of recording.)



Learning Impact

Upon completion of this training, participants will:

  • Gain working knowledge of Design Control requirements across the Total Product Lifecycle (TPLC)
  • Understand the interdependencies across functional responsibilities on successful product design and launch
  • Get an overview of key regulations and guidances
  • Obtain Design Controls Professional Certificate (if all 10 webinar courses are viewed and certificate exam passed)


Certificate of Completion: Each participant will receive a Certificate of Completion for .1 CEUs upon viewing the webinar course and returning a completed evaluation form.

Professional Certificate: Each participant who views all 10 webinar modules and successfully passes the final exam will receive a Professional Certificate (1.0 CEU) from Xavier University. The final exam can be taken remotely after the last module.


$99 per module
$840 for entire series (Receive a 15% discount for purchasing all 10 modules)