Device Changes and the 510(k) - Webinar By GlobalCompliancePanel 2012

Key Topics

• FDA`s and EU`s emphasis
• U.S. FDA device clearance / approval
• Tracking and evaluating changes – the "tipping point"
• Product changes and filing a new 510(k) – who`s responsible
• K-97-1 and the FDA`s "Decision Tree"
• Is the process "risk based"?
• Resolving a "wrong decision"
• Documenting the process / rationale

Who should Attend

• Regulatory Affairs
• Senior Management, Project Leaders, Internal / External Consultants
• R&D and Engineering Staff
• Quality Systems Personnel / QAE
• New product development, regulatory submissions, driving company-wide quality initiatives, under a risk-justified approach
• Personnel involved in Lean and Six Sigma Initiatives
• CAPA personnel desiring to minimize post-production / life cycle, root cause investigation, and other costly problems