Process Verification and Validation Planning and Execution 2012

Key Topics

• Adjusting the Master Validation Plan
• Process Validation -- New regulatory expectations
• When and How to Use DQ, IQ, OQ, PQ
• Product, Process / Equipment V&V
• The 11 Elements of the Software VT&V "Model"
• Using the Risk Management tools of ISO 14971 and ICH Q9
• Avoid recent "horror stories" and multimillion dollar fines

Who should Attend

Regulatory Affairs, Senior management, Production, Quality Assurance, All personnel involved in verification and/or validation planning, execution and documentation, Engineering and including Software from Diagnostic, Medical Device, Biologics fields and Pharmaceutical companies.