Software Verification and Validation in Medical Industry 2015

Topics

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

Who should Attend

• QA/RA Professionals
• Senior management in Drugs, Devices, Biologics, Dietary Supplements
• Engineering Professionals
• R&D Professionals
• Operations Professionals
• Production Professionals
• Consultants