Validation Master Plan - The Unwritten Requirements 2019

Validation Master Plan - The Unwritten Requirements 2019 is an event dedicated to the major cGMP deficiencies and "must have" elements .

Topics

• Verification or Validation - Recent regulatory expectations
• The Individual V&V Plan
• The Master Validation Plan
• When / How to Use DQ, IQ, OQ, PQ, ASTM E2500 Equivalents
• Product V&V versus Process / Equipment V&V
• The 11 Elements of the Software VT&V "Model"
• Using the Risk Management tools of ISO 14971 and ICH Q9
• Key recent compliance problems

Who should Attend

• Senior management
• Quality Assurance
• Regulatory Affairs
• Engineering, including Software
• Production
• All personnel involved in verification and/or validation planning, execution and documentation.