Product Risk Management - ISO 14971:2007 2015

Topics

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

Who should Attend

• 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