Master Verification & Validation Planning under U.S. FDA CGMP, ICH Q-series and ISO 13485-14971 Requirements - Webinar By GlobalCompliancePanel 2012

• The Master Validation Plan / structure
• Verification or Validation - Recent regulatory expectations
• Process / Equipment / Facility Validation -- FDA`s new guidance
• Product Validation – how it differs from process / equipment V&V
• How to use Product Risk Management Tools (per ISO 14971 and ICH Q9)
• When and How to use DQ, IQ, OQ, PQ, or their equivalents
• Incorporating 21 CFR Part 11 requirements
• The 11 key documents for software validation
• Suggested "test case" formats

Master Verification & Validation Planning under U.S. FDA CGMP, ICH Q-series and ISO 13485-14971 Requirements brings together QA, Senior management in Drugs, Devices, Biologics, Dietary Supplements, R&D, RA, Production, Engineering, Consultants and Operations.