The 510(k): Its Purpose, Compilation, and Submission 2014 is a webinar that covers topics such as:
- FDA`s and EU’s emphasis
- FDA device clearance / approval
- Tracking and evaluating changes the "tipping point"
- Product changes and filing a new 510(k) who`s responsible
- The FDA`s "Decision Tree"
- Is the process "risk based"?
- Resolving a "wrong decision"
- Documenting the process / rationale
The 510(k): Its Purpose, Compilation, and Submission 2014 is intended for:
- 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
