Module1: Changes and the 510(k) - (Buy only this webinar)

• FDA device clearance / approval
  
• FDA's and EU’s emphasis
  
• Product changes and filing a new 510(k) – who's responsible
  
• Tracking and evaluating changes – the "tipping point"
  
• Is the process "risk based"?
  

Module2: Master Verification and Validation Planning to Meet US FDA, ISO 13485 and 14971 Requirements - (Buy only this webinar)

• Verification or Validation -- Recent regulatory expectations
  
• The Master Validation Plan
  
• Product Validation – how it differs from process / equipment V&V
  
• Process / Equipment / Facility Validation
  
• When and How to use DQ, IQ, OQ, PQ
  
• How to use your Risk Management Tools (per ISO 14971)
  

Module3: The Design History File and the Technical File / Design Dossier - (Buy only this webinar)

• The U.S. FDA’s Design Control expectations
  
• The DHF’s defined purpose
  
• The EU MDD’s Technical File / Design Dossier’s defined purpose
  
• Similarities and differences – a key to understanding
  
• Some parallel approaches to file development
  

Module4: Product Risk Management - ISO 14971:2007 - (Buy only this webinar)

• The Revised ISO 14971:2007
• Product Hazard Analysis
• Design, Process, and Use[r] Failure Mode, Effects and Criticality Analysis
• Fault Tree Analysis
• The Team and It's Involvement – Who, When and How