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.
