This course offers a unique perspective and is a succinct overview of best practices that can really help you avoid these compliance situations
Areas Covered in the Seminar:
- Inspectional preparations and logistics.
- Manage the FDA Investigator for the best outcome.
- Influence FDA decision-makers.
- Properly accept FDA 483.
- Respond strategically to FDA 483.
- Develop a strategic Corrective Action Plan.
- Intercept and Avoid a Warning Letter.
Who Will Benefit:
- Executive Managers faced with a future FDA inspection
- Personnel with direct and indirect FDA contact prior, during, and after a FDA inspection
- Quality Assurance managers and personnel
- Regulatory Affairs and Compliance managers and personnel
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