This course offers a unique perspective and is a succinct overview of best practices that can really help you avoid these compliance situations, described above
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
Past Events
Best Practices for Managing FDA Investigators and Handling FDA 483 Observations - 30 Sep 2010, Webinar (8660)
Important
Please, check "Best Practices for Managing FDA Investigators and Handling FDA 483 Observations" official website for possible changes, before making any traveling arrangements
Event Categories
Business: Management, Quality assurance
Health & Medicine: Medical device, Medical laboratories, Pharma
