Product Risk Management Under ISO 14971:2007 and ICH Q9 2016

Topics

• ICH Q9 for Pharma
• The Revised ISO 14971:2007 for Devices
• Design, Process, and Use[r] Failure Mode, Effects and Criticality Analysis’
• Product Hazard Analysis
• The Team and It’s Involvement – Who, When and How
• Fault Tree Analysis
• Using the Completed Document – It’s Real Value
• Product Risk Management File and Report
• Keeping it "In the Loop"

Who should Attend

Attendees from:

• Internal / External Auditors and/or Consultants
• Senior Management, Project Leaders
• Quality Systems Personnel / QAE
• Regulatory Affairs
• Product and Process / Manufacturing Engineering Staff
• New product development, Marketing and R&D
• Document Control