Product Risk Management Under ISO 14971 and FDA-ICH Q9 - Webinar By GlobalCompliancePanel 2012

Product Risk Management Under ISO 14971 and FDA-ICH Q9 is a webinar that covers topics such as:

• The Master Validation Plan
• Verification or Validation -- Recent regulatory expectations
• When and How to Use DQ, IQ, OQ, PQ
• 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
• Avoid recent "horror stories" and multimillion dollar fines

Product Risk Management Under ISO 14971 and FDA-ICH Q9 brings together Regulatory Affairs, Senior management, Production, Quality Assurance, All personnel involved in verification and/or validation planning, execution and documentation, Engineering and including Software.