Software Verification and Validation Planning and Documentation 2016

Topics

• The Project Validation Plan
• Verification or Validation - FDA Expectations
• Product and Process / Test / Facilities / Equipment Software V&V
• An FDA-accepted Documentation "Model"
• GAMP / Other Considerations
• When and How to Use DQ, IQ, OQ, PQ (or their equivalents)
• "White Box" and "Black Box" Validations
• The FDA`s 11 Key V&V Documentation Elements

Who should Attend

• Engineering
• R&D
• Operations
• Production
• Consultants