Software Verification and Validation Planning to Meet FDA Requirements 2013

Key Topics

• Current Regulatory Expectations and Recent Audit "Hot Buttons"
• Verification or Validation
• Product and Process / / Facilities / Equipment Software V&V
• The Project Validation Plan
• GAMP / Other Considerations
• When and How to Use DQ, IQ, OQ, PQ (or their equivalents)
• CFR Part 11, QMS, Electronic Records / E-Signatures
• The FDA’s 11 Key V&V Documentation Elements
• "White Box" and "Black Box" Validations

Software Verification and Validation Planning to Meet FDA Requirements brings together QA, Senior management in Drugs, Devices, Biologics, Dietary Supplements, R&D, RA, Production, Engineering, Consultants; others tasked with product, process, electronic records software V&V responsibilities and Operations.