Risk-based Software Verification and Validation - Webinar by GlobalCompliancePanel

Risk-based Software Verification and Validation - Webinar by GlobalCompliancePanel


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About The Event

Overview: The FDA, GAMP and others provide guidance in the methodology and documentation to achieve this. Consideration of the principles in ISO 14971 can assist in providing an acceptable vehicle by which to perform and document risk-based software V&V. This webinar will address the use of the FDA, GAMP, and other applicable industry software validation models, coupled with the ISO 14971 model to structure, run, and document acceptable software validations. 

The U.S. FDA has stated that software validation can only be risk-based. This applies to Software:
  • As-Product
  • In-Product
  • In Production and Test Equipment, and
  • The Quality System.

Areas Covered in the Session:
  • Verification or Validation - Current Regulatory Expectations
  • The Project Validation Plan
  • Product Software Validation and Process / Equipment Software Validations - how they differ
  • When and How to Use DQ, IQ, OQ and PQ
  • ISO 14971:2007 Issues
  • GAMP Guidance
  • The 11 Key Elements of the Software V&V Model
  • "White box" and "Black box" Validations 
  • 'Real World' Considerations

Who Will Benefit:
  • Senior Management, Project Leaders
  • Internal / External Auditors and/or Consultants
  • Regulatory Affairs 
  • Quality Systems Personnel / QAE
  • New product development, Marketing and R&D 
  • Software Product and Process / Manufacturing Engineering Staff
  • Document Control


NetZealous LLC,DBA GlobalCompliancePanel 

161 Mission Falls Lane,Suite 216, Fremont, CA 94539, USA         

 USA Phone:800-447-9407

Fax: 302-288-6884