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Interfacing Design Verification, Process Validation and Design Validation - Webinar By GlobalCompliancePanel

 
  March 02, 2012  
     
 
GlobalCompliancePanel, Online Training
2012-03-13


Overview: There is confusion between the requirements for Design Verification, Process Validation and Design Validation. While each of these processes has its own requirements, they do not stand alone, they are linked together. As this linkage is not well understood, it is the source of FDA observations and potential release of products that do not meet requirements. 

Areas Covered in the Session:
  • Requirements for Design Verification.
  • What is "successful Design Verification"?
  • Requirements for Process Validation
  • What are the inputs to Process Validation from Design?
  • What are the requirements for Design Validation?
  • Where do I get "production products" for Design Validation?
  • What is the impact of Design Change during Design Verification? Process Validation? Design Validation?
Who Will Benefit:
  • Design Engineers and Managers
  • Project Managers
  • Quality Engineers and Managers
  • Process Engineers and Managers
  • Regulatory Affairs
 
 
Organized by: GlobalCompliancePanel
Invited Speakers:
During his 20 year career in medical devices, Mr. Bills has held a number of quality and regulatory affairs positions. Mr. Bills is ASQ Certified as Quality Engineer, Quality Auditor, and as Manager of Quality/ Organizational Improvement. He also holds a certificate as Regulatory Affairs Certified through the Regulatory Affairs Professionals Society, and a BS and Masters degree from the University of Cincinnati. Recently, Mr. Bills served as US Industry Co-chair of the Association for Advancement of Medical Instrumentation committee, QM/WG04, on application of risk management to medical devices and is a current member of this group. Mr. Bills has presented at training courses for the American Association of Medical Instrumentation (AAMI) in the area of risk management and quality systems. Currently, Mr. Bills is the Principal Consultant at Bilanx Consulting LLC in the area of medical device quality, regulatory, product liability and risk management.
 
Deadline for Abstracts: 2012-03-13
 
Registration:
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00

webinars@globalcompliancepanel.com
http://www.globalcompliancepanel.com

Phone: 800-447-9407
Fax: 302-288-6884

E-mail: webinars@globalcompliancepanel.com
 
   
 
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