Design Controls Module 6:
Design Verification and Validation

This module of the Design Control Series explores the requirements for design inputs (including sources for design inputs) and implementation tools to meet the requirements (including how to write good design inputs) in a 1.5-hour webinar. Topics discussed include:

  • Fundamental verification and validation requirements, definitions and terminology
  • Examples of design verification and design validation
  • Integration of current risk management methods
  • Common problems and solutions experienced in design verification and validation
  • FDA viewpoints and experiences

 

Expert Faculty

Julius Aviza
Quality Director
Allergan

William MacFarland
Director, Division of Enforcement B, Office of Compliance
FDA/CDRH

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

Level

Intermediate
 

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)


Certification

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.
 

Price

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