The Most Serious FDA 483s - How to Avoid Them 2019 is a webinar that covers topics such as:
- The "Whys"
- Recent Most Serious FDA 483s
- Avoid complacency from past "good" FDA audits
- Root Causes
- Maximize scarce resources
- Shifting focus
- Maintain "the edge" -- fight "entropy"
- The "risk-based" phased approach
The Most Serious FDA 483s - How to Avoid Them 2019 brings together:
- Regulatory Affairs
- Senior management
- Production
- Quality Assurance
- Engineering