Topics
- Avoid complacency from past "good" FDA audits
- Changing "targets"
- The desired response
- Avoid complacency from just completed "good" ISO audits
- Where to direct scarce resources
- How to respond now -- where to shift focus first
- Maintain "the edge" -- fight "entropy"
- A risk-based phased approach
Who should Attend
Attendees from regulated companies including Regulatory Affairs, Senior management, Production, Quality Assurance and Engineering.