Topics
- Areas impacted by Change Control
- Change Control - what it is; what it is not
- Design Control and Filing a New 510(k)
- Regulatory / FDA 483 "Hot Buttons"
- Identifying Changes
- Document Control
- Give the FDA It`s Desired `State of Control`
- Preventing Negative Changes and Entropy
- Business Needs and Obtaining Stakeholder `Buy-In`
Who should Attend
QA, Senior management in Drugs, Devices, Biologics, Dietary Supplements, R&D, RA, Production, Engineering, Consultants and Operations.
