Verification vs.Validation-Product,Process or Equipment and QMS Software 2018

Topics

• The Project V&V Plan
• Verification or Validation-FDA Expectations
• Product and Process/Test Facilities/Equipment Software V&V
• An FDA-accepted Documentation "Model"
• The FDA`s 11 Key V&V Documentation Elements
• When and How to Use DQ, IQ, OQ, PQ (or their equivalents)
• IEC 62304,GAMP/Other Considerations
• "White Box" and "Black Box" Validations

Who should Attend

• QA / RA
• Senior management in Drugs,Devices,Combination Products,Biologics,Dietary Supplements
• R&D
• Software development,Programming,Documentation,Testing teams
• Production
• Engineering
• Consultants,Others tasked with product,Process,Electronic records software V&V responsibilities
• Operations